PART IIntroductory Provisions Relating to all Medical Devices

Citation and commencement1

These Regulations may be cited as the Medical Devices Regulations 2002 and shall come into force 13th June 2002.

Expiry of certain provisions in these RegulationsF5301ZA

1

Subject to paragraph (3), regulations 19B and 30A cease to have effect at 23:59 on 30 June 2028.

2

Subject to paragraph (3), regulations 19C, 44ZA and 44ZB cease to have effect at 23:59 on 30 June 2030.

3

The following cease to have effect at 23:59 on 30 June 2023—

a

regulation 19B(4), (5), (8) and (9);

b

regulation 19C(8) and (9);

c

regulation 30A(4) to (7);

d

regulation 44ZA(4) and (5);

e

regulation 44ZB(4) and (5).

F360Schedules1A

Schedules 2 and 2A have effect.

InterpretationE752

1

F210... In these Regulations F445...—

  • F293...

  • “active implantable medical device” means a medical device which—

    1. a

      relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; and

    2. b

      is intended to be totally or partially introduced into the human body (whether surgically or medically, including being introduced into a natural orifice) and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced,

    even if it is intended to administer a medicinal product or incorporates as an integral part a substance which, if used separately, would be a medicinal product;

  • F96...

  • F525“approved body” is to be construed in accordance with regulation A45;

  • F355...

  • F231...

  • “CE marking” means a conformity marking consisting of the initials “CE”;

  • F195...

  • F201“clinical data” means the safety or performance information that is generated from the use of a device, derived from—

    1. a

      clinical investigations of the device concerned; or

    2. b

      clinical investigations or other studies reported in scientific literature of a similar device for which equivalence to the device in question can be demonstrated; or

    3. c

      published or unpublished reports on other clinical experiences of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

  • F135“coronavirus test device” means an in vitro diagnostic medical device for the detection of the presence of a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

  • F430“designated standard” has the meaning given in regulation 3A;

  • “device for performance evaluation” means a product which is intended by its manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analysis or in other appropriate environments outside his own premises;

  • F326“Directive 90/385” means Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of Member States relating to active implantable devices F185as it had effect immediately before IP completion day;

  • F131“Directive 93/42” means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices F67as it had effect immediately before IP completion day;

  • F31“Directive 98/79” means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices F471as it had effect immediately before IP completion day;

  • F106...

  • F228“Directive 2003/12” means Commission Directive 2003/12 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices;

  • F469...

  • F55“Directive 2005/50” means Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices;

  • F143“Directive 2007/47” means Directive 2007/47/EC of the European Parliament and of the Council amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market;

  • F546...

  • “F265... CAB” shall be construed in accordance with regulation 48(1);

  • F311...

  • F320...

  • F167...

  • F410“hazard” means a potential source of injury or damage to health;

  • F553“hip, knee or shoulder replacement” means an implantable component part of a total joint replacement system which is intended to provide a function similar to that of either a natural hip joint, a natural knee joint or a natural shoulder joint, other than ancillary components (screws, wedges, plates and instruments);

  • F269“intended for clinical investigation” means—

    1. a

      intended for use by a registered medical practitioner when conducting investigations of that device in an adequate human clinical environment; or

    2. b

      intended for use by any other person in F507Great Britain who, by virtue of their professional qualification, is authorised to carry out investigations of that device in an adequate human clinical environment;

  • “intended purpose” means—

    1. a

      in relation to an active implantable medical device, the use for which it is intended and for which it is suited according to the data supplied by the manufacturer in the instructions relating to it;

    2. b

      in relation to any other medical device, the use to which the device is intended according to the data supplied by the manufacturer on the labelling, the instructions for use and/or the promotional materials;

  • “in vitro diagnostic medical device” means a medical device which—

    1. a

      is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and

    2. b

      is intended by the manufacturer to be usedin vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information—

      1. i

        concerning a physiological or pathological state,

      2. ii

        concerning a congenital abnormality,

      3. iii

        to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or

      4. iv

        to monitor therapeutic measures,

      and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used forin vitro diagnostic examination;

  • F234“machinery” has the meaning given to it by F377regulation 4 of the Supply of Machinery (Safety) Regulations 2008;

  • “manufacturer” means—

    1. a

      the person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; or

    2. b

      any other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient;

  • “medical device” means F513any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which—

    1. a

      is intended by the manufacturer to be used for human beings for the purpose of-

      1. i

        diagnosis, prevention, monitoring, treatment or alleviation of disease,

      2. ii

        diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

      3. iii

        investigation, replacement or modification of the anatomy or of a physiological process, or

      4. iv

        control of conception; and

    2. b

      does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,

    and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;

  • “the Medical Devices Directives” means Directive 90/385, Directive 93/42, F443both read with Regulation (EU) No 207/2012 and Regulation (EU) No 722/2012 and Directive 98/79;

  • F84...

  • “medicinal product” has the meaning given in F204regulation 2(1) of the Human Medicines Regulations 2012;

  • F121“mutual recognition agreement” means an agreement that—

    1. a

      is between the United Kingdom and a country listed in Schedule 2, and

    2. b

      covers matters including the conditions under which the United Kingdom and F10that country will accept or recognise the results of conformity assessment procedures undertaken by the each other's designated bodies;

  • F498...

  • F20...

  • F275...

  • “placing on the market” means, in relation to a medical device, the first making available in return for payment or free of charge of a new or fully refurbished device, other than a device intended for clinical investigation, with a view to distribution, use, or both, on the F80Great Britain market F156and related expressions must be construed accordingly;

  • “putting into service” means—

    1. a

      in relation to an active implantable medical device, the making available of the device to a registered medical practitioner for implantation;

    2. b

      in relation to any other medical device, the first making available of the device in F425Great Britain to a final user, including where a device is used in a professional context for the purposes of medical analysis without being marketed;

  • F257“Regulation (EU) No 207/2012” means Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices;F116(as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act)

  • “Regulation (EU) No 722/2012” means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin; F518(as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act)

  • F258“Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC;

  • F258“Regulation (EU) 2017/746” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU;

  • F690“Regulation (EU) 2022/1107” means Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council;

  • “relevant essential requirements”, in relation to a medical device, means the essential requirements set out in Annex 1 of Directive 90/385, Annex I of Directive 93/42 or Annex I of Directive 98/79 which apply to it, but not including, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation;

  • “specimen receptacle” means a medical device which (whether vacuum-type or not) is specifically intended by its manufacturer to be used for the primary containment and preservation of specimens derived from the human body for the purpose ofin vitro diagnostic examination;

  • “stable derivatives device” means a medical device that contains human blood, blood products, plasma or blood cells of human origin, and which incorporates, as an integral part, a substance which—

    1. a

      if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of F17regulation 2(2) of the Human Medicines Regulations 2012; and

    2. b

      is liable to act upon the human body with action ancillary to that of the device;

  • F531“statistical review” means a review of the statistical sections of the written notice which a manufacturer or their UK responsible person submits to the Secretary of State pursuant to regulation 16(1) or 29(1) in respect of an intended clinical investigation of a relevant device;

  • “supply”, in relation to a medical device, means—

    1. a

      the supply of, or the offer or agreement to supply, the device; or

    2. b

      the exposure or possession for supply of the device;

  • F489“third country conformity assessment body” means a body established in a country which is listed in Schedule 2 and designated in accordance with a relevant mutual recognition agreement to carry out conformity assessment procedures for the purposes of these Regulations;

  • F500...

  • F341“UK marking” has the meaning given in Article 2(22) of Regulation (EC) No 765/2008; and

  • F274...

  • F502“UK responsible person” means a person established in any part of the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer's obligations under these regulations.

F3431A

In these Regulations, any reference to Annexes 1 to 7 to Directive 90/385, Annexes I to X to Directive 93/42 or Annex I to X to Directive 98/79 is to be construed as a reference to those Annexes F165as they applied immediately before IP completion day and as modified by Schedule 2A.

F5491B

In these Regulations, any reference to Annex 1 to Directive 90/385 or to Annex I to Directive 93/42 is to that Annex read with Regulation (EU) No 207/2012.

2

In these Regulations, unless the context otherwise requires, a reference—

a

to a numbered regulation, Part or Schedule is to the regulation or Part of, or the Schedule to, these Regulations bearing that number;

b

in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; and

c

in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter.

InterpretationE92

1

In these RegulationsF659...—

  • F293...

  • “active implantable medical device” means a medical device which—

    1. a

      relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; and

    2. b

      is intended to be totally or partially introduced into the human body (whether surgically or medically, including being introduced into a natural orifice) and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced,

    even if it is intended to administer a medicinal product or incorporates as an integral part a substance which, if used separately, would be a medicinal product;

  • F596...

  • “Association Agreement” means an Agreement, listed in Schedule 1, establishing an Association between the European Communities and their Member States, on the one part, and another State on the other part (referred to in these Regulations as a “State which is a Party to an Association Agreement”) on Conformity Assessment and Acceptance of Industrial Products;

  • F35“authorised representative” means a person established within a relevant state, explicitly designated by the manufacturer who is not a person established in a relevant state, who acts for the manufacturer and may be addressed by authorities and bodies in a relevant state instead of the manufacturer with regard to the latter’s obligation under Directive 90/385, Directive 93/42 and Directive 98/79;

  • “CE marking” means a conformity marking consisting of the initials “CE”;

  • “the Community” means—

    1. a

      in the context of any requirement relating to an in vitro diagnostic medical device, the F595European Union;

    2. b

      in the context of any requirement relating to any other medical device, the European Economic Area;

  • F657“clinical data” means the safety or performance information that is generated from the use of a device, derived from—

    1. a

      clinical investigations of the device concerned; or

    2. b

      clinical investigations or other studies reported in scientific literature of a similar device for which equivalence to the device in question can be demonstrated; or

    3. c

      published or unpublished reports on other clinical experiences of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

  • F135“coronavirus test device” means an in vitro diagnostic medical device for the detection of the presence of a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

  • “device for performance evaluation” means a product which is intended by its manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analysis or in other appropriate environments outside his own premises;

  • F571“Directive 90/385” means Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of Member States relating to active implantable devices;

  • F638“Directive 93/42” means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices;

  • F654“Directive 98/79” means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices;

  • “Directive 2001/83” means Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community Code relating to medicinal products for human use F579F671as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use;

  • F647“Directive 2003/12” means Commission Directive 2003/12 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices;

  • F609...

  • F673“Directive 2005/50” means Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices;

  • F574“Directive 2007/47” means Directive 2007/47/EC of the European Parliament and of the Council amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market;

  • “Directive 2006/42/EC” means Directive 2006/42/EC of the European Parliament and of the Council on machinery;

  • “F236... CAB” shall be construed in accordance with regulation 48(1);

  • F684...

  • F598“European Economic Area” means the European Economic Area created by the EEA Agreement;

  • “harmonised standard” means—

    1. a

      a technical specification adopted, on a mandate from the European Commission, by the European Committee for Standardisation or the European Committee for Electrotechnical Standardisation, or by both of those bodies, in accordance with Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations F633, pursuant to the general guidelines on co-operation between the Commission and the said Committees signed on 13th November 1984; or

    2. b

      a monograph of the European Pharmacopoeia (in particular any monograph on surgical sutures and the interaction between medicinal products and materials used in medical devices containing medicinal products),

    the reference number of which has been published in the Official Journal of the F595European Union;

  • F607“hazard” means a potential source of injury or damage to health;

  • F603“hip, knee or shoulder replacement” means an implantable component part of a total joint replacement system which is intended to provide a function similar to that of either a natural hip joint, a natural knee joint or a natural shoulder joint, other than ancillary components (screws, wedges, plates and instruments);

  • F680“intended for clinical investigation” means—

    1. a

      intended for use by a registered medical practitioner when conducting investigations of that device in an adequate human clinical environment; or

    2. b

      intended for use by any other person in a F183relevant state who, by virtue of their professional qualification, is authorised to carry out investigations of that device in an adequate human clinical environment;

  • “intended purpose” means—

    1. a

      in relation to an active implantable medical device, the use for which it is intended and for which it is suited according to the data supplied by the manufacturer in the instructions relating to it;

    2. b

      in relation to any other medical device, the use to which the device is intended according to the data supplied by the manufacturer on the labelling, the instructions for use and/or the promotional materials;

  • “in vitro diagnostic medical device” means a medical device which—

    1. a

      is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and

    2. b

      is intended by the manufacturer to be usedin vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information—

      1. i

        concerning a physiological or pathological state,

      2. ii

        concerning a congenital abnormality,

      3. iii

        to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or

      4. iv

        to monitor therapeutic measures,

      and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used forin vitro diagnostic examination;

  • F634“machinery” has the meaning given to it by Article 2(a) of Directive 2006/42;

  • “manufacturer” means—

    1. a

      the person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; or

    2. b

      any other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient;

  • F164“medical device” has the meaning given in Article 2(1) of Regulation (EU) 2017/745 and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;

  • “the Medical Devices Directives” means Directive 90/385, Directive 93/42, F616both read with Regulation (EU) No 207/2012 and Regulation (EU) No 722/2012 and Directive 98/79;

  • F611...

  • “medicinal product” has the meaning given in article 1.2 of Directive 2001/83;

  • “Mutual Recognition Agreements” means the agreements, listed in Schedule 2, concluded between the European Community and States which are not part of the European Community on matters including the conditions under which each Party will accept or recognise the results of the conformity assessment procedures undertaken by the other Party’s designated bodies;

  • “national standard” means a technical specification adopted by F461a relevant state which transposes, and corresponds to, a harmonised standard;

  • F582...

  • “notified body” means a body authorised in accordance with F650Part V or the Medical Devices Directives to carry out tasks of a notified body or the importing Party under the Medical Devices Directives or the Mutual Recognition Agreements in respect of a conformity assessment procedure;

  • “placing on the market” means, in relation to a medical device, the first making available in return for payment or free of charge of a new or fully refurbished device, other than a device intended for clinical investigation, with a view to distribution, use, or both, on F404a relevant state market;

  • “putting into service” means—

    1. a

      in relation to an active implantable medical device, the making available of the device to a registered medical practitioner for implantation;

    2. b

      in relation to any other medical device, the first making available of the device in F297a relevant state to a final user, including where a device is used in a professional context for the purposes of medical analysis without being marketed;

  • F578“Regulation (EU) No 207/2012” means Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices;

  • “Regulation (EU) No 722/2012” means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin;

  • F23“Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC;

  • F691“Regulation (EU) 2017/746” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU;

  • “Regulation (EU) 2022/1107” means Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council;

  • “relevant essential requirements”, in relation to a medical device, means the essential requirements set out in Annex 1 of Directive 90/385, Annex I of Directive 93/42 or Annex I of Directive 98/79 which apply to it, but not including, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation;

  • F141“relevant market” means a market of a relevant state;

  • “relevant state” means—

    1. a

      in relation to any requirement relating to an in vitro diagnostic medical device, Northern Ireland or a Member State of the European Union;

    2. b

      in relation to any requirement relating to any other medical device, Northern Ireland or a state in the European Economic Area;

    3. c

      a State other than a Member State of the European Union which is a Party to an Association Agreement (where applicable under that Association Agreement);

  • “specimen receptacle” means a medical device which (whether vacuum-type or not) is specifically intended by its manufacturer to be used for the primary containment and preservation of specimens derived from the human body for the purpose ofin vitro diagnostic examination;

  • “stable derivatives device” means a medical device that contains human blood, blood products, plasma or blood cells of human origin, and which incorporates, as an integral part, a substance which—

    1. a

      if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of article 1.10 of Directive 2001/83; and

    2. b

      is liable to act upon the human body with action ancillary to that of the device;

  • “supply”, in relation to a medical device, means—

    1. a

      the supply of, or the offer or agreement to supply, the device; or

    2. b

      the exposure or possession for supply of the device;

  • “third country conformity assessment body” means a body in a State which is not part of the Community that is designated in accordance with the Mutual Recognition Agreements to carry out tasks of a notified body under the conformity assessment procedures set out in the Medical Devices Directives;

  • F602...

  • F141“UK mutual recognition agreement” means an agreement between the United Kingdom and another country that covers matters including the conditions under which the United Kingdom and that country will accept or recognise the results of the conformity assessment procedures undertaken by each other’s designated bodies;

  • “UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) indication) (EU Exit) Regulations 2020;

  • “UK notified body” shall be construed in accordance with regulation 45; and

  • F141“UK responsible person” is to be construed in accordance with regulation 19B(2) for the purposes of Part II, regulation 21C(2) for the purposes of Part III and regulation 44A(2) for the purposes of part IV.

F6781A

In these Regulations, any reference to Annexes 1 to 7 to Directive 90/385, Annexes I to X to Directive 93/42 or Annex I to X to Directive 98/79 is to be construed as a reference to those Annexes as amended from time to time.

F6621B

In these Regulations, any reference to Annex 1 to Directive 90/385 or to Annex I to Directive 93/42 is to that Annex read with Regulation (EU) No 207/2012.

2

In these Regulations, unless the context otherwise requires, a reference—

a

to a numbered regulation, Part or Schedule is to the regulation or Part of, or the Schedule to, these Regulations bearing that number;

b

in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; and

c

in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter.

F128Medical devices which are qualifying Northern Ireland goods2A

1

F692Subject to paragraph (1A), notwithstanding the effect of regulations 19B, 19C, 30A, 44ZA and 44ZB and the expiry of the period during which those regulations apply by virtue of regulation 1ZA, any medical device—

F693a

which meets the requirements of—

i

these Regulations as they apply in Northern Ireland;

b

which is a qualifying Northern Ireland good,

may be placed on the Great Britain market as if it meets the requirements of these Regulations as they apply in Great Britain.

F6941A

Before 25 July 2024, paragraph (1) only applies to a coronavirus test device that meets the requirements of Regulation (EU) 2017/746 if the device also meets the requirements of—

a

regulation 34A (approval requirement for coronavirus test devices); or

b

the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107.

2

In this regulation,

F86a

“qualifying Northern Ireland good” has the meaning given in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

F301b

“Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

Scope of these RegulationsE113

These Regulations shall not apply to—

a

medicinal products governed by F138the Human Medicines Regulations 2012 (including medicinal products derived from human blood or human plasma F353...);

b

human blood, human blood products, plasma or blood cells of human origin;

c

devices that incorporate, at the time of placing on the market, human blood, blood products, plasma or blood cells of human origin, except for F282—

i

stable derivatives devices,

ii

active implantable medical devices and accessories to such devices, and

iii

in vitro diagnostic medical devices and accessories to such devices,;

d

transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin F545, except for F266..., in vitro diagnostic medical devices and accessories to such devicesF315save where medicinal products are incorporated as ancillary to the device;

F422e

transplants or tissues or cells of animal origin, unless—

i

a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue, or

ii

a product is F12... an in vitro diagnostic medical device, or an accessory to such a device;

f

cosmetic products governed by F432Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30th November 2009 on cosmetic products; or

F323g

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Scope of these RegulationsE363

These Regulations shall not apply to—

a

medicinal products governed by Directive 2001/83 (including medicinal products derived from human blood or human plasma governed by Title X of Directive 2001/83);

b

human blood, human blood products, plasma or blood cells of human origin;

c

devices that incorporate, at the time of placing on the market, human blood, blood products, plasma or blood cells of human origin, except for F663—

i

stable derivatives devices,

ii

active implantable medical devices and accessories to such devices, and

iii

in vitro diagnostic medical devices and accessories to such devices,;

d

transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin F644, except for F661..., in vitro diagnostic medical devices and accessories to such devicesF652save where medicinal products are incorporated as ancillary to the device;

F583e

transplants or tissues or cells of animal origin, unless—

i

a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue, or

ii

a product is F687... an in vitro diagnostic medical device, or an accessory to such a device;

f

cosmetic products governed by Council Directive 76/768/EECF656, as amended F629; or

F576g

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F515Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 F695and Regulation (EU) 2017/7463ZA

F6961

Subject to paragraph (2), Parts 2 to 7 only apply in Northern Ireland for the purpose of regulating qualifying devices.

2

The following provisions continue to apply in Northern Ireland in accordance with this paragraph F697...—

F698a

for the purposes of the registration of medical devices (whether or not they are qualifying devices) and persons placing medical devices on the market in Northern Ireland—

i

regulation 19 (registration of persons placing general medical devices on the market),

ii

regulation 21B (registration of persons placing active implantable medical devices on the market),

iii

regulation 44 (registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation), and

iv

regulation 53 (fees in connection with the registration of devices and changes to registration details),

only apply until the date which is 24 months after the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745;

aa

regulations 34A to 34D, 38A to 38C, 39A, 56A, 59 and 61 continue to apply in relation to coronavirus test devices whether or not they are qualifying devices;

b

Parts 5 to 7 F699also apply for purposes related to the designation of conformity assessment bodies for the purposes of a UK mutual recognition agreement.

3

F700For the purposes of this regulation, a device is a qualifying device if, by virtue of Article 120 of Regulation (EU) 2017/745 F701or Article 110 of Regulation (EU) 2017/746—

a

it may be placed on the market, put into service or made available in Northern Ireland in accordance with the requirements of F702Directive 90/385, Directive 93/42 or Directive 98/79, rather than Regulation (EU) 2017/745 or Regulation (EU) 2017/746; and

b

it is placed on the market, put into service or made available in Northern Ireland in accordance with, and subject to the requirements of and the arrangements set out in, Parts 2 F703... to 7.

F98Designated standard3A

1

In Parts II, III and IV of these Regulations, a “designated standard” means—

a

a technical specification which is—

i

adopted by a recognised standardisation body F295or an international standardising body, for repeated or continuous application with which compliance is not compulsory; and

ii

designated by the Secretary of State by publishing a reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate; or

b

a monograph of the European Pharmacopoeia (in particular on surgical sutures and on the interaction between medicinal products and materials used in devices containing medicinal products) which has been published in the Official Journal of the European Union.

2

For the purposes of paragraph (1), a “technical specification” means a document which prescribes technical requirements to be fulfilled by a device, process, service or system (“the product”) and which lays down—

a

the characteristics required of a product, including levels of quality, performance, interoperability, environmental protection, health and safety and dimensions;

b

the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

c

the production methods and processes relating to the product, where these have an effect on its characteristics.

3

For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations—

a

the European Committee for Standardisation (CEN);

b

the European Committee for Electrotechnical Standardisation (CENELEC);

c

the British Standards Institute (BSI).

F2813A

In this regulation “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).

4

When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

5

Before publishing the reference to a standard in relation to a technical specification which has been adopted by BSI, the Secretary of State must have regard to whether the technical specification is consistent with F514such technical specifications adopted by the other recognised standardisation bodies F542or by international standardising bodies as the Secretary of State considers to be relevant.

6

The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

7

Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

8

In this regulation—

a

a reference to a “device” is a reference to a medical device or its accessory or an in vitro diagnostic medical device or its accessory to which these Regulations apply;

b

a reference to “the European Pharmacopoeia” is a reference to the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia.

ConfidentialityF4143B

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transitional provisions4

1

Part II shall not be applied before 1st July 2004 in respect of a device which has been subjected to EEC pattern approval before 1st January 1995 in accordance with the Clinical Thermometers (EEC Requirements) Regulations 1993 M1.

2

Part II shall not be applied—

a

before 10th January 2007 in respect of a stable derivatives device placed on the market without a CE marking, if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 10th January 2002; or

b

before 10th January 2009 in respect of a stable derivatives device put into service without a CE marking, if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 10th January 2002.

3

Part IV shall not be applied before 7th December 2003 in respect of a device placed on the market which is—

a

anin vitro diagnostic medical device without a CE marking; or

b

a device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,

if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 7th December 1998.

4

Part IV shall not be applied before 7th December 2005 in respect of a device put into service which is—

a

anin vitro diagnostic medical device without a CE marking; or

b

a device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,

if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is put into service as in force on 7th December 1998.

F4915

Regulation 13(4) shall not be applied before 1st March 2004 in respect of breast implants which—

a

bore a CE marking before 1st September 2003; and

b

satisfy the requirements in respect of relevant devices falling within Class IIb set out in regulation 13(3).

F266

Regulation 19A shall not be applied before 1st October 2004 in respect of a device placed on the market before 1st April 2004.

F346Transitional provisions for hip, knee and shoulder replacements4A

1

This regulation applies to hip, knee or shoulder replacements.

2

Regulation 13(4) shall not apply in respect of a replacement—

a

whose manufacturer or his authorised representative has before 1st September 2007—

i

fulfilled the applicable obligations imposed by Annex II, excluding Section 4 of that Annex,

ii

declared, in accordance with a declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it, and

iii

ensured that the device meets the provisions of Directive 93/42 which apply to it; and

b

in respect of which an examination under Section 4 of Annex II has been carried out and an EC design-examination certificate under that Section has been issued before 1st September 2009.

3

Regulation 13(4) shall not apply before 1st September 2009 in respect of a replacement—

a

whose manufacturer or his authorised representative has—

i

fulfilled the applicable obligations imposed by Annex II, excluding Section 4 of that Annex,

ii

declared, in accordance with a declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it, and

iii

ensured that the device meets the provisions of Directive 93/42 which apply to it; and

b

which is covered by the decision of a notified body issued in accordance with Section 3.3 or 3.4 of Annex II before 1st September 2007.

4

Regulation 13(4) shall not apply before 1st September 2010 in respect of replacement—

a

whose manufacturer or his authorised representative has—

i

fulfilled the applicable obligations imposed by Annex III together with Annex VI,

ii

declared, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it, and

iii

ensured that the device meets the provisions of Directive 93/42 which apply to it; and

b

which is covered by the decision of a notified body issued in accordance with Section 3.3 or 3.4 of Annex VI before 1st September 2007.

5

Regulation 13(4) shall not apply in respect of a replacement which—

a

satisfies the conditions set out in paragraph (4)(a) and (b);

b

has been placed on the market before 1st September 2010; and

b

is put into service on or after that date.

F224Revocations, transitional and saving provisions in respect of the new national registration requirements4D

1

Regulation 19 is revoked on the day that is 4 months after IP completion day (which is when regulation 7A comes into force).

2

Regulation 7A does not apply until the day that is 8 months after IP completion day in respect of a device or accessory—

a

that is a relevant device for the purposes of Part II; and

b

that is classified as belonging to—

i

Class IIa, as referred to in regulation 7, or

ii

Class IIb, as referred to in regulation 7, and is also a Group A device (within the meaning given in regulation 52(1)).

3

Regulation 7A does not apply until the day that is 12 months after IP completion day in respect of a device or accessory—

a

that is a relevant device for the purposes of Part II; and

b

that is classified as belonging to Class I, as referred to in regulation 7.

4

Where regulation 7A does not apply in respect of a device or accessory by virtue of paragraph (2) or (3), regulation 19 continues to have effect after its revocation in respect of that device or accessory.

6

Regulation 30(3) is revoked on the day that is 4 months after IP completion day (which is when regulation 21A comes into force).

8

Regulation 44 is revoked on the day that is 4 months after IP completion day (which is when regulation 33A comes into force).

9

Regulation 33A does not apply until the day that is 8 months after IP completion day in respect of a device or accessory—

a

that is a relevant device for the purposes of Part IV, or

b

that is—

i

referred to in List B, mentioned in regulation 40(4), or

ii

a device for self-testing (as defined in relation 32(1)).

10

Regulation 33A does not apply until the day that is 12 months after IP completion day in respect of a device or accessory that is a relevant device for the purposes of Part IV which follows the procedure in regulation 40(1).

11

Where regulation 33A does not apply in respect of a device or accessory by virtue of paragraph (9), regulation 44 continues to have effect after its revocation in respect of that device or accessory.

Revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date4H

1

Commission Decision 2002/364/EC of 7 May 2002 on the common specifications for in vitro diagnostic medical devices F184... is revoked on 26th May 2025.

F1332

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation of Commission Decision 2010/2274I

Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) is revoked.

F523Revocation of Commission Regulation (EU) No 207/2012 on 26th May 20254J

Commission Regulation (EU) No 207/2012 is revoked on 25th May 2025.

F361Revocation of Regulation (EU) No 722/2012 on 26th May 20254K

Regulation (EU) No 722/2012 is revoked on 26th May 2025.

Revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date4L

1

Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of F424approved bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (“Regulation (EU) No 920/2013”) (insofar as it is retained EU law) is revoked on 26th May 2025.

F1144

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4765

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation of Regulation (EU) No 2017/2185 and saving provision4M

1

Insofar as it is retained EU law, Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (“Regulation (EU) No 2017/2185”) is revoked.

The classification criteria in Directives 2003/12 and 2005/50F694N

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation of Regulation (EU) 2017/7454O

1

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (“the Medical Devices Regulation”) (insofar as it is retained EU law) is revoked.

Revocation of Regulation (EU) 2017/7464P

1

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“the in vitro diagnostic medical devices Regulation”) (insofar as it is retained EU law) is revoked.

References in other legislation to Directives 90/385, 93/42 and 98/794T

F7041

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

In regulation 10(5) of the Medicines (Products for Human Use) (Fees) Regulations 2016 (fee for advice for other purposes)—

a

the reference to the expression “medical device” having the meaning given in Article 1(2)(a) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as a reference also or instead to having the meaning given in regulation 2; and

F126b

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F332c

the reference to the expression “Directive 93/42/EEC” is to be construed, to the extent necessary for the practical application of that expression, as a reference also or instead to Part II of the Medical Devices Regulations 2002;

d

the references to “paragraph 4.3 of Annex II to Directive 93/42/EEC” and “paragraph 5 of Annex III to Directive 93/42/EEC” are to be construed, to the extent necessary for the practical application of those provisions, as references also or instead to those paragraphs and those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A.

3

In Schedule 1 to the Pressure Equipment (Safety) Regulations 2016 (excluded pressure equipment and assemblies), the reference in paragraph 1(f)(iv) to not being covered by Directive 93/42 is to be construed, to the extent necessary for the practical application of that provision, as a reference also or instead to not being covered by Part II.

4

In regulation 2 of the Waste Electrical and Electronic Equipment Regulations 2013 (interpretation)—

a

the reference to the expression “active implantable medical device” having the meaning given in Article 1(2)(c) of Directive 90/385 is to be construed, to the extent necessary for the practical application of that definition, as a reference also or instead to it having the meaning given in regulation 2 F537...;

b

the reference to the expression “medical device” having the meaning given in Article 1(2)(a) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as a reference to it also or instead having the meaning given to it in regulation 2;

c

the reference to the expression “accessory” having the meaning given in Article 1(2)(b) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as also or instead having the meaning given to “accessory” in regulation 5;

d

the reference to the expression “in vitro diagnostic medical device” having the meaning given in Article 1(2)(b) of Directive 98/79 is to be construed, to the extent necessary for the practical application of that definition, as having the meaning given to it in regulation 2;

e

the reference to the expression “accessory” having the meaning given in Article 1(2)(c) of Directive 98/79 is to be construed, to the extent necessary for the practical application of that definition, as also or instead having the meaning given to “accessory” in regulation 32.

5

These Regulations are an enactment implementing a relevant Community Directive for the purposes of regulation 4 of the Personal Protective Equipment at Work Regulations (Northern Ireland) 1993 (provision of personal protective equipment).

6

These Regulations are also an enactment implementing a relevant Community Directive for the purposes of regulation 4(5)(a) of the Personal Protective Equipment at Work Regulations 1992 (provision of personal protective equipment).

PART IIGeneral Medical Devices

Interpretation of Part II5

1

In this Part F362...—

  • “accessory” means an article which, whilst not being a medical device, is intended specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the medical device intended by its manufacturer;

  • “custom-made device” means a relevant device that is—

    1. a

      manufactured specifically in accordance with a written prescription of a F382registered medical practitioner, or other person authorised to write such a prescription by virtue of his professional qualification, which gives, under his responsibility, specific characteristics as to its design; and

    2. b

      intended for the sole use of a particular patient,

    but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user;

  • “relevant device” shall be construed in accordance with regulation 6;

  • “single-use combination product” means a product which comprises a medical device and medicinal product forming a single integral product which is intended exclusively for use in the given combination and which is not reusable; and

  • “system or procedure pack” has the same meaning as in article 12 of Directive 93/42.

2

In this Part F362..., a reference to a numbered article or Annex is to the article or Annex of Directive 93/42 bearing that number.

Scope of Part II6

The requirements of this Part in respect of relevant devices apply in respect of medical devices (including stable derivatives devices), accessories to such devices, single-use combination products, and systems and procedure packs, other than—

a

active implantable medical devices and accessories to such devices; F110and

b

in vitro diagnostic medical devices and accessories to such devices; F383and

c

F449devices that come within the scope of Directive 93/42 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

i

the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and

ii

the manufacturer chooses to follow the set of arrangements in the other Directive.

Classification of general medical devicesE547

1

For the purposes of this Part and Part VI, devices are classified as belonging to Class I, IIa, IIb or III in accordance with the classification criteria set out in Annex IX of Directive 93/42 F340, read with Directive 2003/12F336and Directive 2005/50.

2

In the event of a dispute between a manufacturer and F169an approved body over the classification of a device, the matter shall be referred to the Secretary of State, who shall determine the classification of the device in accordance with the classification criteria set out in Annex IX of Directive 93/42 F340, read with Directive 2003/12F336and Directive 2005/50.

Classification of general medical devicesE647

1

For the purposes of this Part and Part VI, devices are classified as belonging to Class I, IIa, IIb or III in accordance with the classification criteria set out in Annex IX of Directive 93/42 F585, read with Directive 2003/12F666and Directive 2005/50.

2

In the event of a dispute between a manufacturer and a notified body over the classification of a device, the matter shall be referred to the Secretary of State, who shall determine the classification of the device in accordance with the classification criteria set out in Annex IX of Directive 93/42 F585, read with Directive 2003/12F666and Directive 2005/50.

F510Registration of persons placing general medical devices on the market7A

1

No person may place a relevant device on the market in accordance with this Part unless that person—

a

is established in Great Britain; and

b

has complied with paragraph (2).

2

A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—

a

where—

i

that person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;

ii

that person is the manufacturer of that device and is based outside the United Kingdom, the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; or

iii

that person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;

b

that person supplies the Secretary of State with a description of the relevant device; and

c

that person pays to the Secretary of State the relevant fee in accordance with regulation 53.

2A

The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

3

The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—

a

ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

b

keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

c

in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

d

where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access;

e

where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;

f

cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

g

immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;

h

if the manufacturer acts contrary to its obligations under these Regulations—

i

terminate the legal relationship with the manufacturer; and

ii

inform the Secretary of State and, if applicable, the relevant approved body of that termination.

4

In this regulation—

a

the references to “technical documentation” are to be construed in accordance with Annex II, III or VII;

b

the references to “declaration of conformity” are to be construed in accordance with Annexes II, IV, V, VI and VII.

Essential requirements for general medical devicesE698

1

Subject to regulation 12, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it F144and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

2

Subject to regulation 12, no person shall supply a relevant device—

a

if that supply is also a placing on the market or putting into service of that device; or

b

in circumstances where that device has been placed on the market or put into service,

unless that device meets those essential requirements set out in Annex I which apply to it F401and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

F1233

Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in F192Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.

Essential requirements for general medical devicesE518

1

Subject to regulation 12, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it F624and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

2

Subject to regulation 12, no person shall supply a relevant device—

a

if that supply is also a placing on the market or putting into service of that device; or

b

in circumstances where that device has been placed on the market or put into service,

unless that device meets those essential requirements set out in Annex I which apply to it F618and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

F6373

Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Annex I to Directive 2006/42 to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.

Determining compliance of general medical devices with relevant essential requirementsE609

1

In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

2

Where confirmation of conformity with the essential requirements must be based on clinical data, such data must be established in accordance with the requirements set out in Annex X.

3

In the case of a relevant device which is being or has been put into service—

a

the essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); and

b

the essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if—

i

such instructions are in English F506...

F34ii

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant F517designated standard, unless there are reasonable grounds for suspecting that it does not comply with that requirement.

5

A custom-made device—

a

in respect of which the conditions specified in Annex VIII are satisfied; and

b

in the case of a Class IIa, Class IIb and Class III device, which is accompanied by the statement required by Section 1 of Annex VIII,

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

F1365A

When a custom-made device is supplied to a patient, the healthcare professional who writes the prescription for the custom-made device shall, in relation to each patient that they supply with such a device—

a

ensure that the patient is aware that they may request the statement containing the information required by Sections 1 and 2 of Annex VIII; and

b

ensure that the statement containing the information required by Sections 1 and 2 of Annex VIII is made available to the patient on request.

6

Where, in accordance with Section 2.1 of Annex VIII, a manufacturer of a custom-made device, or F239their UK responsible person, has indicated that specified essential requirements have not been fully met, and has given proper grounds as to why they have not been fully met, those specified essential requirements are no longer to be treated as relevant essential requirements for that device.

7

A device intended for clinical investigation in respect of which—

a

the conditions specified in Annex VIII are satisfied;

b

notice has been given under regulation 16(1); and

c

either—

i

no notice has been given under regulation 16(4) within the period of 60 days there referred to, or

ii

notice has been given under regulation 16(5),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

8

A single-use combination product shall be taken to comply with the relevant essential requirements if the medical device which forms part of that product only complies with the requirements set out in Annex I F558... that relate to safety and performance, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device, in which case the single-use combination product must comply with all the relevant essential requirements which apply to it.

F2609

Where a device is intended by the manufacturer to be used in conjunction with both the provisions in F566Regulation (EU) 2016/425 of the European Parliament and of the Council of 9th March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC and Directive 93/42, the relevant basic health and safety requirements of F564Regulation (EU) 2016/425 shall also be fulfilled.

Determining compliance of general medical devices with relevant essential requirementsE829

1

In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

2

Where confirmation of conformity with the essential requirements must be based on clinical data, such data must be established in accordance with the requirements set out in Annex X.

3

In the case of a relevant device which is being or has been put into service—

a

the essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); and

b

the essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if—

i

such instructions are in English or another Community language, and

ii

if the instructions are not in English, any packaging, label or promotional literature carries a clear statement in English stating the language in which the instructions are given.

4

A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant national standard, unless there are reasonable grounds for suspecting that it does not comply with that requirement.

5

A custom-made device—

a

in respect of which the conditions specified in Annex VIII are satisfied; and

b

in the case of a Class IIa, Class IIb and Class III device, which is accompanied by the statement required by Section 1 of Annex VIII,

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

F6455A

When a custom-made device is supplied to a patient, the healthcare professional who writes the prescription for the custom-made device shall, in relation to each patient that they supply with such a device—

a

ensure that the patient is aware that they may request the statement containing the information required by Sections 1 and 2 of Annex VIII; and

b

ensure that the statement containing the information required by Sections 1 and 2 of Annex VIII is made available to the patient on request.

6

Where, in accordance with Section 2.1 of Annex VIII, a manufacturer of a custom-made device, or his authorised representative, has indicated that specified essential requirements have not been fully met, and has given proper grounds as to why they have not been fully met, those specified essential requirements are no longer to be treated as relevant essential requirements for that device.

7

A device intended for clinical investigation in respect of which—

a

the conditions specified in Annex VIII are satisfied;

b

notice has been given under regulation 16(1); and

c

either—

i

no notice has been given under regulation 16(4) within the period of 60 days there referred to, or

ii

notice has been given under regulation 16(5),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

8

A single-use combination product shall be taken to comply with the relevant essential requirements if the medical device which forms part of that product only complies with the requirements set out in Annex I of Directive 93/42 that relate to safety and performance, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device, in which case the single-use combination product must comply with all the relevant essential requirements which apply to it.

F6069

Where a device is intended by the manufacturer to be used in conjunction with both the provisions in Council Directive 89/686/EEC on the approximation or the laws of the Member States relating to personal protective equipment and Directive 93/42, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.

F227UK marking of general medical devicesE6310

1

Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device or its sterile pack bears a F478UK marking which—

a

meets the requirements set out in F492Annex 2 of Regulation (EC) No 765/2008;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant F289approved body or conformity assessment body identification number for that device.

2

Subject to regulations 12 and 14, no person shall supply a relevant device unless, where practical and appropriate, that device or its sterile pack bears a F544UK marking which—

a

meets the requirements set out in F402Annex 2 of Regulation (EC) No 765/2008;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant F124approved body or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service.

3

Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless F296a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008, appears on—

a

any sales packaging for that device; and

b

the instructions for use for the device,

and that F393UK marking is accompanied by any relevant F134approved body or conformity assessment body identification number for that device.

4

Subject to regulations 12 and 14, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless F101a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008, appears on—

a

any sales packaging for that device; and

b

the instructions for use for the device,

and that F242UK marking is accompanied by any relevant F82approved body or conformity assessment body identification number for that device.

5

No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

a

a relevant device or its sterile pack;

b

the instructions for use for a relevant device; or

c

any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the F321UK marking or which reduces the visibility or the legibility of the F321UK marking.

F3346

In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—

a

as not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and

b

as allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).

CE marking of general medical devicesE4510

1

Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device or its sterile pack bears a CE marking which—

a

meets the requirements set out in Annex XII;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant notified body or conformity assessment body identification number for that device.

2

Subject to regulations 12 and 14, no person shall supply a relevant device unless, where practical and appropriate, that device or its sterile pack bears a CE marking which—

a

meets the requirements set out in Annex XII;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant notified body or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service.

3

Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless a CE marking, meeting the requirements set out in Annex XII, appears on—

a

any sales packaging for that device; and

b

the instructions for use for the device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

4

Subject to regulations 12 and 14, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a CE marking, meeting the requirements set out in Annex XII, appears on—

a

any sales packaging for that device; and

b

the instructions for use for the device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

5

No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

a

a relevant device or its sterile pack;

b

the instructions for use for a relevant device; or

c

any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the CE marking or which reduces the visibility or the legibility of the CE marking.

Annotations:
Extent Information
E45

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

F460UK(NI) indication: general medical devices10A

1

Where the CE marking referred to in regulation 10 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.

2

The UK(NI) indication must be affixed—

a

visibly, legibly and indelibly; and

b

before a relevant device is placed on the market in Northern Ireland.

3

The UK(NI) indication must accompany the CE marking, wherever such marking is affixed in accordance with regulation 13.

F43A

The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.

4

The UK(NI) indication must be affixed by the manufacturer.

5

Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.

6

No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service.

F501 UK marking of general medical devices that come within the scope of this Part and other legislationE7711

Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied.

CE marking of general medical devices that come within the scope of more than one DirectiveE2811

Where a relevant device comes within the scope of Directive 93/42 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, no person shall affix a CE marking to the device unless the relevant requirements of the other Directive are also satisfied, except where—

a

the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it;

b

the manufacturer chooses to follow the set of arrangements in Directive 93/42;

c

the marking of the device indicates that the device only satisfies the set of arrangements chosen by the manufacturer; and

d

the particulars of Directive 93/42, as published in the Official Journal of the F568European Union, are given in the documents, notices or instructions accompanying the device.

Exemptions from regulations 8 and 10E3312

1

A relevant device or a single use combination product being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of F267... these Regulations.

2

Regulation 10 shall not apply to a custom-made device or a device intended for clinical investigation.

3

Regulation 10 shall not apply to a relevant device which is a system or procedure pack, unless—

a

the system or procedure pack incorporates a medical device which does not bear a F457UK marking; or

b

the chosen combination of medical devices is not compatible in view of their original intended use.

4

Regulation 10 shall not apply to single-use combination products, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device which forms part of that product.

5

Regulations 8 and 10 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a F351UK marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

F1256

Regulations 8 and 10 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards, or which is marked other than with a UK marking, which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 8 and 10, may be placed on the market.

7

In paragraph (6), the Secretary of State, in determining whether another standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 8 and 10, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.

Exemptions from regulations 8 and 10E9112

1

A relevant device or a single use combination product being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of Directive 93/42 or these Regulations.

2

Regulation 10 shall not apply to a custom-made device or a device intended for clinical investigation.

3

Regulation 10 shall not apply to a relevant device which is a system or procedure pack, unless—

a

the system or procedure pack incorporates a medical device which does not bear a CE marking; or

b

the chosen combination of medical devices is not compatible in view of their original intended use.

4

Regulation 10 shall not apply to single-use combination products, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device which forms part of that product.

5

Regulations 8 and 10 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

Annotations:
Extent Information
E91

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Procedures for affixing a F285UK marking to general medical devicesE7413

1

A relevant device falling within Class I may bear a F541UK marking only if its manufacturer or F235their UK responsible person—

a

fulfils the applicable obligations imposed by Annex VII;

b

declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of F303this Part which apply to it; and

c

ensures that the device meets the provisions of F303this Part which apply to it.

2

A relevant device falling within Class IIa may bear a F541UK marking only if its manufacturer or F235their UK responsible person—

a

fulfils the applicable obligations imposed by—

i

Annex II, excluding Section 4 of that Annex, or

ii

Annex VII, together with Annex IV, V or VI;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of F303this Part which apply to it; and

c

ensures that the device meets the provisions of F303this Part which apply to it.

3

A relevant device falling within Class IIb may bear a F541UK marking only if its manufacturer or F235their UK responsible person—

a

fulfils the applicable obligations imposed by—

i

Annex II, excluding Section 4 of that Annex, or

ii

Annex III, together with Annex IV, V or VI;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of F303this Part which apply to it; and

c

ensures that the device meets the provisions of F303this Part which apply to it.

4

A relevant device falling within Class III may bear a F541UK marking only if its manufacturer or F235their UK responsible person—

a

fulfils the applicable obligations imposed by—

i

Annex II, or

ii

Annex III, together with Annex IV or V;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of F303this Part which apply to it; F524...

c

ensures that the device meets the provisions of F303this Part which apply to it; F487and

F365d

fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).

F4945

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4946

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Procedures for affixing a CE marking to general medical devicesE8713

1

A relevant device falling within Class I may bear a CE marking only if its manufacturer or his authorised representative—

a

fulfils the applicable obligations imposed by Annex VII;

b

declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it; and

c

ensures that the device meets the provisions of Directive 93/42 which apply to it.

2

A relevant device falling within Class IIa may bear a CE marking only if its manufacturer or his authorised representative—

a

fulfils the applicable obligations imposed by—

i

Annex II, excluding Section 4 of that Annex, or

ii

Annex VII, together with Annex IV, V or VI;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it; and

c

ensures that the device meets the provisions of Directive 93/42 which apply to it.

3

A relevant device falling within Class IIb may bear a CE marking only if its manufacturer or his authorised representative—

a

fulfils the applicable obligations imposed by—

i

Annex II, excluding Section 4 of that Annex, or

ii

Annex III, together with Annex IV, V or VI;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it; and

c

ensures that the device meets the provisions of Directive 93/42 which apply to it.

4

A relevant device falling within Class III may bear a CE marking only if its manufacturer or his authorised representative—

a

fulfils the applicable obligations imposed by—

i

Annex II, or

ii

Annex III, together with Annex IV or V;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it; F589...

c

ensures that the device meets the provisions of Directive 93/42 which apply to it; F674and

F610d

fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).

F6395

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6396

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Procedures for systems and procedure packs, and for devices to be sterilised before useE314

1

Subject to paragraph (3), no person shall supply a system or procedure pack (if that supply is also a placing on the market, or if that supply is of a system or procedure pack that has been placed on the market) unless—

a

the medical devices in that system or procedure pack are for use within their intended purpose and within the limits of use specified by their manufacturer;

b

the person who places or has placed it on the market has drawn up a declaration that—

i

he has verified the mutual compatibility of the medical devices in that system or procedure pack in accordance with the manufacturers’ instructions, and he has carried out his operations in accordance with these instructions,

ii

he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers, and

iii

his production of the system or procedure pack is subjected to appropriate methods of internal control and inspection,

and that declaration is true at the time it is made and continues to be true.

2

Subject to paragraph (3), no person shall supply—

a

a system or procedure pack which was sterilised before being placed on the market; or

b

a relevant device (including a system or procedure pack) which is designed by its manufacturer to be sterilised before use,

(if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless the person who places, or who has placed, the device on the market satisfies the conditions set out in paragraph (4).

3

Paragraphs (1) and (2)(a) shall only apply to a system or procedure pack if, by virtue of regulation 12(3), regulation 10 does not apply to that system or procedure pack.

4

The conditions referred to in paragraph (2) are that the person shall—

F409a

follow the procedures referred to in either Annex II or IV that relate to obtaining sterility; and

b

if the device has been sterilised, make a written declaration that sterilisation has been carried out in accordance with the manufacturer’s instructions.

F4134A

The application of Annex II or IV and the intervention of the F132approved body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged.

5

Where a conformity assessment procedure is carried out in respect of a relevant device (including a device which is a system or procedure pack) pursuant to this regulation—

a

no person shall affix a F567UK marking to that device as a result of that procedure; and

b

no person shall supply that device (if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless it is accompanied by the information referred to in Section 13 of Annex I, which shall include, where appropriate, the information supplied by the manufacturers of the devices which have been put together.

6

The declarations referred to in paragraph (1)(b) and (4)(b) shall be kept available for the Secretary of State by the person responsible for placing the product on the market for a period of five years.

Procedures for systems and procedure packs, and for devices to be sterilised before useE3014

1

Subject to paragraph (3), no person shall supply a system or procedure pack (if that supply is also a placing on the market, or if that supply is of a system or procedure pack that has been placed on the market) unless—

a

the medical devices in that system or procedure pack are for use within their intended purpose and within the limits of use specified by their manufacturer;

b

the person who places or has placed it on the market has drawn up a declaration that—

i

he has verified the mutual compatibility of the medical devices in that system or procedure pack in accordance with the manufacturers’ instructions, and he has carried out his operations in accordance with these instructions,

ii

he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers, and

iii

his production of the system or procedure pack is subjected to appropriate methods of internal control and inspection,

and that declaration is true at the time it is made and continues to be true.

2

Subject to paragraph (3), no person shall supply—

a

a system or procedure pack which was sterilised before being placed on the market; or

b

a relevant device (including a system or procedure pack) which is designed by its manufacturer to be sterilised before use,

(if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless the person who places, or who has placed, the device on the market satisfies the conditions set out in paragraph (4).

3

Paragraphs (1) and (2)(a) shall only apply to a system or procedure pack if, by virtue of regulation 12(3), regulation 10 does not apply to that system or procedure pack.

4

The conditions referred to in paragraph (2) are that the person shall—

F660a

follow the procedures referred to in either Annex II or IV that relate to obtaining sterility; and

b

if the device has been sterilised, make a written declaration that sterilisation has been carried out in accordance with the manufacturer’s instructions.

F5874A

The application of Annex II or IV and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged.

5

Where a conformity assessment procedure is carried out in respect of a relevant device (including a device which is a system or procedure pack) pursuant to this regulation—

a

no person shall affix a CE marking to that device as a result of that procedure; and

b

no person shall supply that device (if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless it is accompanied by the information referred to in Section 13 of Annex I, which shall include, where appropriate, the information supplied by the manufacturers of the devices which have been put together.

6

The declarations referred to in paragraph (1)(b) and (4)(b) shall be kept available for the Secretary of State by the person responsible for placing the product on the market for a period of five years.

Procedures for custom-made general medical devicesE5815

No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or F516their UK responsible person—

a

has drawn up a statement containing the information required by Sections 1, 2 and 2.1 of Annex VIII F74, read with Regulation (EU) No 722/2012;

b

has undertaken to keep available for the Secretary of State documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of Directive 93/42; and

c

takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex VIII; F97...

d

keeps available for the Secretary of State, for a minimum period of five years, the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b) F47; and

e

ensures that the statement is passed on with the custom-made device so that it may be made available to the patient on request.

Procedures for custom-made general medical devicesE6615

No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or his authorised representative—

a

has drawn up a statement containing the information required by Sections 1, 2 and 2.1 of Annex VIII F677, read with Regulation (EU) No 722/2012;

b

has undertaken to keep available for the Secretary of State documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of Directive 93/42; and

c

takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex VIII; F615...

d

keeps available for the Secretary of State, for a minimum period of five years, the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b) F588; and

e

ensures that the statement is passed on with the custom-made device so that it may be made available to the patient on request.

Procedures for general medical devices for clinical investigationsE7216

1

Subject to paragraph (2), no person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in F442Great Britain unless, before he does so, the manufacturer of the device or F310their UK responsible person has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—

a

subject to paragraph (3), the statement required by F179Sections 1 and 2.2 of Annex VIII F172, read with Regulation (EU) No 722/2012; and

b

an undertaking to keep available for the Secretary of State the documentation referred to in Section 3.2 of Annex VIII for a minimum period of five years.

F3131A

A manufacturer or their UK responsible person may request a meeting with the Secretary of State in advance of giving notice in writing to the Secretary of State pursuant to paragraph (1) in order to—

a

obtain advice on regulatory requirements relating to an intended clinical investigation; or

b

obtain a statistical review in relation to an intended clinical investigation.

2

Paragraph (1) shall not apply in respect of an intended clinical investigation of a relevant device that bears a F32UK marking otherwise than in breach of regulation 13, unless the aim of the intended investigation is to determine whether the device may be used for a purpose other than that in respect of which it was F93UK marked in accordance with regulation 13.

3

The ethics committee opinion that forms part of the information required under Section 2.2 of Annex VIII need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or F310their UK responsible person as soon as it becomes available.

4

If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer F539or UK responsible person (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.

5

The Secretary of State may, in respect of notice in writing given by a manufacturer or F310their UK responsible person pursuant to paragraph (1), give written notice to the manufacturer or F310their UK responsible person—

a

that the relevant device may be made available for the purposes of the intended investigation; or

b

if the ethics committee opinion required under Section 2.2 of Annex VIII is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.

6

A written notice pursuant to paragraph (5) may—

a

where appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;

b

at any time be withdrawn on grounds of public health or public policy by the Secretary of State.

7

Where a written notice pursuant to paragraph (5) in respect of a relevant device has been withdrawn by the Secretary of State—

a

further clinical use of the relevant device in the investigation is prohibited; and

b

no person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),

unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.

8

The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or F310their UK responsible person, shall—

a

take all necessary measures to ensure that the manufacturing process for the relevant device produces devices manufactured in accordance with the documentation referred to in the first paragraph of Section 3.2 of Annex VIII;

b

authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation; and

c

keep the information contained in the statement and the undertaking referred to in paragraph (1) for a minimum period of five years.

9

The grounds of public health or public policy referred to in paragraph (4) or (6)(b) are met, amongst other reasons, if—

a

the manufacturer or F310their UK responsible person does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (8); or

b

the manufacturer or F310their UK responsible person does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1)(b).

10

No person shall conduct a clinical investigation of a relevant device—

a

otherwise than in accordance with Annex X; and

b

otherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (6)(a),

and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or F310their UK responsible person shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex X.

F50511

The manufacturer, or their F223single UK responsible person, shall—

a

notify the Secretary of State of the end of the clinical investigation; and

b

provide justification where premature termination has resulted.

Procedures for general medical devices for clinical investigationsE1216

1

Subject to paragraph (2), no person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in F379Northern Ireland unless, before he does so, the manufacturer of the device or his authorised representative has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—

a

subject to paragraph (3), the statement required by F628Sections 1 and 2.2 of Annex VIII F672, read with Regulation (EU) No 722/2012; and

b

an undertaking to keep available for the Secretary of State the documentation referred to in Section 3.2 of Annex VIII for a minimum period of five years.

2

Paragraph (1) shall not apply in respect of an intended clinical investigation of a relevant device that bears a CE marking otherwise than in breach of regulation 13, unless the aim of the intended investigation is to determine whether the device may be used for a purpose other than that in respect of which it was CE marked in accordance with regulation 13.

3

The ethics committee opinion that forms part of the information required under Section 2.2 of Annex VIII need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or his authorised representative as soon as it becomes available.

4

If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer or authorised representative (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.

5

The Secretary of State may, in respect of notice in writing given by a manufacturer or his authorised representative pursuant to paragraph (1), give written notice to the manufacturer or his authorised representative—

a

that the relevant device may be made available for the purposes of the intended investigation; or

b

if the ethics committee opinion required under Section 2.2 of Annex VIII is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.

6

A written notice pursuant to paragraph (5) may—

a

where appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;

b

at any time be withdrawn on grounds of public health or public policy by the Secretary of State.

7

Where a written notice pursuant to paragraph (5) in respect of a relevant device has been withdrawn by the Secretary of State—

a

further clinical use of the relevant device in the investigation is prohibited; and

b

no person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),

unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.

8

The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or his authorised representative, shall—

a

take all necessary measures to ensure that the manufacturing process for the relevant device produces devices manufactured in accordance with the documentation referred to in the first paragraph of Section 3.2 of Annex VIII;

b

authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation; and

c

keep the information contained in the statement and the undertaking referred to in paragraph (1) for a minimum period of five years.

9

The grounds of public health or public policy referred to in paragraph (4) or (6)(b) are met, amongst other reasons, if—

a

the manufacturer or his authorised representative does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (8); or

b

the manufacturer or his authorised representative does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1)(b).

10

No person shall conduct a clinical investigation of a relevant device—

a

otherwise than in accordance with Annex X; and

b

otherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (6)(a),

and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or his authorised representative shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex X.

F59411

The manufacturer, or their single authorised representative, shall—

a

notify the Secretary of State of the end of the clinical investigation; and

b

provide justification where premature termination has resulted.

Manufacturers etc. and conformity assessment procedures for general medical devicesE5917

1

A manufacturer of a relevant device or, where applicable, F380their UK responsible person who is required to follow, or follows or has followed a conformity assessment procedure set out in F59this Part shall observe the manufacturer’s obligations set out in that procedure that apply to him.

2

A manufacturer of a relevant device or, where applicable, F380their UK responsible person shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with F59this Part at an intermediate stage of manufacture of the device.

F703

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3574

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3575

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturers etc. and conformity assessment procedures for general medical devicesE2217

1

A manufacturer of a relevant device or, where applicable, his authorised representative who is required to follow, or follows or has followed a conformity assessment procedure set out in Directive 93/42 shall observe the manufacturer’s obligations set out in that procedure that apply to him.

2

A manufacturer of a relevant device or, where applicable, his authorised representative shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 93/42 at an intermediate stage of manufacture of the device.

F3143

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6414

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6415

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F423Approved bodies and the conformity assessment procedures for general medical devicesE3118

1

F483An approved body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

a

take account of the results of any assessment or verification operations which have been carried out F148... at an intermediate stage of manufacture of the device;

b

take account of any relevant information relating to the characteristics and performance of that device, F108...; and

c

lay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annex II to IV.

2

Where F495an approved body takes a decision in accordance with F246Annex II, III, V or VI, they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.

3

Where F339an approved body and a manufacturer or F356the manufacturer’s UK responsible person have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or F356the manufacturer’s UK responsible person, extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.

F3314

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

UK notified bodies and the conformity assessment procedures for general medical devicesE218

1

A UK notified body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

a

take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 93/42 at an intermediate stage of manufacture of the device;

b

take account of any relevant information relating to the characteristics and performance of that device, including in particular the results of any relevant tests and verification relating to that device already carried out under the laws or administrative provisions in force before 1st January 1995 in any F592EEA State; and

c

lay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annex II to IV.

2

Where a UK notified body takes a decision in accordance with F664Annex II, III, V or VI, they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.

3

Where a UK notified body and a manufacturer or his authorised representative have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or his authorised representative, extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.

F6314

Decisions taken by UK notified bodies before 1st September 2003 in accordance with Annex II in respect of breast implants may not be extended.

F450F408Registration of persons placing general medical devices on the market19

1

Paragraph (2) applies—

a

in relation to relevant devices that are neither Class I devices nor custom-made devices, to—

i

a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland any general medical device of any class, other than a system or procedure pack which is not CE marked;

F345ii

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iii

a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;

iv

a manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;

b

in relation to Class I devices F40that are not custom-made devices, to—

i

a manufacturer who places a device on the Northern Ireland market and has a registered place of business in Northern Ireland;

ii

an authorised representative with a registered place of business in Northern Ireland;

c

to a person with a registered place of business in Northern Ireland who sterilises before use any devices designed by their manufacturer to be sterilised before use.

2

For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—

a

inform the Secretary of State of their address and registered place of business;

b

supply the Secretary of State with a description of each category of device concerned;

F196c

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

d

in the case of an authorised representative, supply the Secretary of State with—

i

written evidence that they have been designated as an authorised representative;

ii

details of the person who has so designated them; and

iii

where the person placing the devices concerned on the market is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market;

e

inform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.

3

The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of any of the dates specified in paragraph (4) that apply in respect of a particular case.

4

The obligations in paragraph (2) begin to apply—

a

in the case of a device that is a Class I device and custom-made devices, on 1st January 2021;

b

in the case of a device that is a Class III or IIb implantable device, on 1st May 2021;

c

in the case of a device that is a Class IIa or Class IIb non-implantable device, on 1st September 2021.

F4485

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3906

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Additional requirements relating to use of animal tissuesF32219A

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F705F139Obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/4219B

1

In this regulation—

a

“the Directive” means Directive 93/42 F122as it had effect on 25 May 2021 and any reference to an Article or Annex is a reference to that Article or Annex in the Directive F85...;

b

“Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it has effect in EU law;

c

“CE marking” means the CE marking required by Article 17 and shown in Annex XII;

d

“harmonised standard” is to be construed in accordance with Article 5.

2

Where paragraph (3) applies regulations 8, 9, 10(1) to (4), 11 and 13 are treated as being satisfied.

3

F54Subject to paragraph (3A), this paragraph applies where, before placing a relevant device other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—

a

ensures—

i

that the device meets the essential requirements set out in Annex I and, where applicable, Regulation 722/2012, which apply to it; or

ii

that paragraph (10) and (11) apply;

b

ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 11;

F350ba

ensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;

c

ensures that the documentation required by the conformity assessment procedure is drawn up;

d

ensures that the technical and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English;

e

affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes II, III, IV, V, VI or VII;

f

F99has drawn up before 26 May 2021 an EU declaration of conformity in accordance with Article 11; and

g

ensures that the declaration of conformity is prepared in or translated into English.

F3193A

Paragraph (3) only applies to a class I device under the Directive if—

a

the conformity assessment procedure under Article 11 required the involvement of a notified body; or

b

the conformity assessment procedure for that device under Article 52 of Regulation (EU) 2017/745 would require the involvement of a notified body (if it were to be assessed under that regulation).

4

Where paragraph (5) applies, regulations 8 and 15 are treated as being satisfied.

5

This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—

a

has drawn up a statement in English containing the information required by Section 1 and specified in Section 2.1 of Annex VIII, read with Regulation 722/2012;

b

has undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow an assessment of conformity of the device with the requirements of the Directive;

c

undertakes to the Secretary of State—

i

to comply with Section 3.1 of Annex VIII;

ii

to keep all documentation required by Annex VIII available in accordance with Section 4 of Annex VIII; and

iii

to pass the statement mentioned in subparagraph (a) on with the custom-made device so that it may be made available to the patient on request.

6

Where paragraph (7) applies, regulations 8 and 14 are treated as being satisfied.

7

This paragraph applies where before a system or procedure pack is placed on the market, the manufacturer—

a

has complied with Article 12(2);

b

has complied with Article 12(3) and with the procedure in Annex II or V;

F499ba

ensures that any certificate in relation to the system or procedure pack or a device within it that was issued by a notified body under the Directive is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;

bb

ensures that the declarations required by Article 12 were drawn up before 26 May 2021;

c

undertakes to keep the declarations required by Article 12 for the period specified in Article 12(4); F392...

d

ensures that the system or procedure pack is accompanied by the information referred to in point 13 of Annex I which must be in F39English; and

F273e

ensures that the system or procedure pack does not contain a class I device under the Directive for which—

i

the conformity assessment procedure under Article 11 did not require the involvement of a notified body; and

ii

the conformity assessment procedure under Article 52 of Regulation (EU) 2017/745 would not require the involvement of a notifed body (if it were to be assessed under that regulation).

8

Where paragraph (9) applies, regulations 8 and 16 are treated as being satisfied.

9

This paragraph applies where before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—

a

has provided the Secretary of State with the relevant written notice which must be in English in the form of the Statement required by Sections 1 and 2.2 of Annex VIII;

b

undertakes to keep available the documentation referred to in Section 3.2 of Annex VIII for the period specified in Section 4 of that Annex; and

c

has taken all necessary measures to ensure that the manufacturing process for the device produces devices in accordance with the documentation referred to in the first paragraph of paragraph 3.1 of Annex VIII.

10

Where paragraph (11) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4).

11

This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.

12

For the purpose of this regulation in regulations 10(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.

Obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/74519C

1

In this regulation—

a

“the Regulation” means Regulation (EU) 2017/745, as it has effect in EU law, and any reference to an Article or an Annex is a reference to an Article or Annex of the Regulation;

b

“CE marking” means the CE marking required by Article 20 and presented in Annex V;

c

“harmonised standard” has the meaning given in Article 2(70);

d

“sponsor” has the meaning given in Article 2(49).

2

Where paragraph (3) applies, regulations 8, 10(1) to (4), 11, 13, 22, 23, 24 and 27 are treated as being satisfied.

3

This paragraph applies where, before placing a relevant device within the meaning of Part II or Part III (as the case may be) other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—

a

ensures—

i

that the device meets the general safety and performance requirements in Annex I which apply to it; or

ii

that paragraphs (10) and (11) apply;

b

ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 52;

F147ba

ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn;

c

ensures that the documentation required by the relevant conformity assessment procedure is drawn up;

d

ensures that the technical documentation required by Annexes II and III and other relevant documentation required by a relevant conformity assessment procedure is prepared in or translated into English;

e

affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes IX, X or XI;

f

draws up an EU declaration of conformity in accordance with Article 19;

g

ensures that the declaration of conformity is prepared in or translated into English.

4

Where paragraph (5) applies regulations 8 and 15 (or as the case may be) 22 and 28 are treated as being satisfied.

5

This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—

a

has drawn up a statement in English containing the information specified in Section 1 of Annex XIII;

b

has undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent national authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow assessment of the conformity of the device with the requirements of the Regulation; and

c

undertakes to comply with Sections 3 (manufacturing), 4 (retention of information) and 5 (review of experience) of Annex XIII.

6

Where paragraph (7) applies, regulations 8 and 14 are treated as being satisfied.

F2767

This paragraph applies where, before a system or procedure pack is placed on the market, the person responsible for combining devices to produce that system or procedure pack—

a

has complied with the relevant requirements of Article 22 including where that Article requires a conformity assessment in accordance with Annex IX or XI; and

b

ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn.

8

Where paragraph (9) applies, regulations 8 and 16(1) or (as the case may be) 22 and 29(1) are treated as being satisfied.

9

This paragraph applies where, before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—

a

has provided the Secretary of State with the required notice in the form of the application required by Article 70 in English; and

b

has provided the Secretary of State with an undertaking to keep available documentation contained in the application in accordance with Section 3 of Chapter III of Annex XV.

10

Where paragraph (11) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4) or regulation 23(4) (as the case may be).

11

This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.

12

For the purpose of this regulation in regulations 10(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.

PART IIIActive Implantable Medical Devices

Interpretation of Part III20

1

In this PartF58...—

  • “custom-made device” means an active implantable medical device that is—

    1. a

      manufactured specifically in accordance with a medical specialist’s written prescription which gives, under his responsibility, specific characteristics as to its design; and

    2. b

      intended to be used only for a particular patient; and

  • “relevant device” shall be construed in accordance with regulation 21.

2

In this PartF58..., a reference to a numbered F255... Annex is to the F255... Annex of Directive 90/385 bearing that number.

Scope of Part IIIE2721

F3161

The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, F127...

F382

Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in F441Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.

F523

Where an active implantable device is intended to administer a medicinal product, that device must be governed by this Part without prejudice to the provisions of the Human Medicines Regulations 2012.

F1464

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Scope of Part IIIE621

F5811

The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, except for devices that come within the scope of Directive 90/385 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

a

the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it; and

b

the manufacturer chooses to follow the set of arrangements in the other Directive.

F6252

Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.

3

Where an active implantable medical device is intended to administer a medicinal product, that device shall be governed by Directive 90/385 without prejudice to the provisions of Directive 2001/83/EC.

F199Registration of persons placing active implantable medical devices on the market21A

1

No person may place a relevant device on the market in accordance with this Part unless that person—

a

is established in Great Britain; and

b

has complied with paragraph (2).

2

A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—

a

where—

i

that person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;

ii

that person is the manufacturer of that device and is based outside the United Kingdom, and the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; or

iii

that person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;

b

that person supplies the Secretary of State with a description of the relevant device; and

c

that person pays to the Secretary of State the relevant fee in accordance with regulation 53.

2A

The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

3

The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—

a

ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

b

keep available to the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

c

in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

d

where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access;

e

where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;

f

cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

g

immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;

h

if the manufacturer acts contrary to its obligations under these Regulations—

i

terminate the legal relationship with the manufacturer; and

ii

inform the Secretary of State and, if applicable, the relevant approved body of that termination.

4

In this regulation—

a

the references to “technical documentation” are to be construed in accordance with Annex 2, 3 or 5;

b

the references to “declaration of conformity” are to be construed in accordance with Annexes 2, 3 and 5.

F250Registration of persons placing active implantable medical devices on the market21B

1

Paragraph (2) applies—

a

in relation to relevant devices other than custom-made devices, to—

i

a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland any relevant device;

F230ii

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iii

a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;

iv

a manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;

F474b

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—

a

inform the Secretary of State of the address of their registered place of business; and

b

supply the Secretary of State with a description of each category of device concerned;

F381c

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

d

in the case of an authorised representative, supply the Secretary of State with—

i

written evidence that they have been designated as an authorised representative;

ii

details of the person who has so designated them; and

iii

where the person placing the devices concerned on the market is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market;

e

inform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.

3

The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of the date specified in paragraph (4).

4

The obligations in paragraph (2) begin to apply on 1st May 2021.

F165

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F2326

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Requirement to appoint a UK responsible person for active implantable medical devicesF70621C

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Essential requirements for active implantable medical devices22

1

Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex 1 which apply to it F207and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

2

Subject to regulation 26, no person shall supply a relevant device—

a

if that supply is also a placing on the market or putting into service of that device; or

b

in circumstances where that device has also been placed on the market or put into service,

unless that device meets those essential requirements set out in Annex 1 which apply to it F363and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

Determining compliance of active implantable medical devices with relevant essential requirementsE5023

1

In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

2

Any—

a

determination that a relevant device complies with any of the essential requirements set out in paragraphs 1 to 5 of Annex 1; and

b

evaluation of side effects or undesirable effects for the purposes of determining whether or not a relevant device complies with any of the essential requirements,

shall be based in particular on clinical data, the adequacy of which is based on the collation of scientific literature or the results of clinical investigations referred to in paragraph 1 of Annex 7, and any determination as to whether or not a relevant device complies with any other essential requirements may be based on such data.

3

In the case of a relevant device which is being or has been put into service—

a

the essential requirements specified in paragraph 14 of Annex 1 are complied with only if the particulars there specified are in English (whether or not they are also in another language and whether or not the device is for professional use); and

b

the essential requirements specified in paragraph 13 of Annex 1, so far as they relate to instructions required for the operation of a device in paragraph 15 of Annex 1, are complied with only if—

i

the instructions are in English F533...

F130ii

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant F509designated standard, unless there are reasonable grounds for suspecting that the device does not comply with that requirement.

5

A custom-made device in respect of which the conditions specified in Annex 6 are satisfied and which is accompanied by the statement referred to in paragraph 1 of Annex 6 shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

6

A device intended for clinical investigation in respect of which—

a

the conditions specified in Annex 7 are satisfied;

b

notice has been given under regulation 29(1); and

c

either—

i

no notice has been given under regulation 29(3) within the period of 60 days there referred to, or

ii

notice has been given under regulation 29(4),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

Determining compliance of active implantable medical devices with relevant essential requirementsE8923

1

In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

2

Any—

a

determination that a relevant device complies with any of the essential requirements set out in paragraphs 1 to 5 of Annex 1; and

b

evaluation of side effects or undesirable effects for the purposes of determining whether or not a relevant device complies with any of the essential requirements,

shall be based in particular on clinical data, the adequacy of which is based on the collation of scientific literature or the results of clinical investigations referred to in paragraph 1 of Annex 7, and any determination as to whether or not a relevant device complies with any other essential requirements may be based on such data.

3

In the case of a relevant device which is being or has been put into service—

a

the essential requirements specified in paragraph 14 of Annex 1 are complied with only if the particulars there specified are in English (whether or not they are also in another language and whether or not the device is for professional use); and

b

the essential requirements specified in paragraph 13 of Annex 1, so far as they relate to instructions required for the operation of a device in paragraph 15 of Annex 1, are complied with only if—

i

the instructions are in English or another Community language, and

ii

if the instructions are not in English, any packaging, label or promotional literature carries a clear statement in English stating the language in which the instructions are given.

4

A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant national Standard, unless there are reasonable grounds for suspecting that the device does not comply with that requirement.

5

A custom-made device in respect of which the conditions specified in Annex 6 are satisfied and which is accompanied by the statement referred to in paragraph 1 of Annex 6 shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

6

A device intended for clinical investigation in respect of which—

a

the conditions specified in Annex 7 are satisfied;

b

notice has been given under regulation 29(1); and

c

either—

i

no notice has been given under regulation 29(3) within the period of 60 days there referred to, or

ii

notice has been given under regulation 29(4),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

Annotations:
Extent Information
E89

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

F403UK marking of active implantable medical devicesE1924

1

Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device or its sterile pack bears a F415UK marking which—

a

meets the requirements set out in F439Annex 2 of Regulation 765/2008;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant F213approved body or conformity assessment body identification number for that device.

2

Subject to regulation 26, no person shall supply a relevant device unless that device or its sterile pack bears a F415UK marking which—

a

meets the requirements set out in F439Annex 2 of Regulation 765/2008;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant F368approved body or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service.

3

Subject to regulation 26, no person shall place on the market or put into service a relevant device unless a F415UK marking, meeting the requirements set out in F439Annex 2 of Regulation 765/2008, appears on—

a

where appropriate, any sales packaging for that device; and

b

the instructions for use for the device,

and that F415UK marking is accompanied by any relevant F56approved body or conformity assessment body identification number for that device.

4

Subject to regulation 26, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a F415UK marking, meeting the requirements set out in F439Annex 2 of Regulation 765/2008, appears on—

a

where appropriate, any sales packaging for that device; and

b

the instructions for use for the device,

and that F415UK marking is accompanied by any relevant F540approved body or conformity assessment body identification number for that device.

5

No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

a

a relevant device or its sterile pack;

b

the instructions for use for a relevant device; or

c

where appropriate, any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the F415UK marking or which reduces the visibility or the legibility of the F415UK marking.

F2116

In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—

a

as not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and

b

as allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).

CE marking of active implantable medical devicesE9224

1

Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device or its sterile pack bears a CE marking which—

a

meets the requirements set out in Annex 9;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant notified body or conformity assessment body identification number for that device.

2

Subject to regulation 26, no person shall supply a relevant device unless that device or its sterile pack bears a CE marking which—

a

meets the requirements set out in Annex 9;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant notified body or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service.

3

Subject to regulation 26, no person shall place on the market or put into service a relevant device unless a CE marking, meeting the requirements set out in Annex 9, appears on—

a

where appropriate, any sales packaging for that device; and

b

the instructions for use for the device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

4

Subject to regulation 26, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a CE marking, meeting the requirements set out in Annex 9, appears on—

a

where appropriate, any sales packaging for that device; and

b

the instructions for use for the device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

5

No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

a

a relevant device or its sterile pack;

b

the instructions for use for a relevant device; or

c

where appropriate, any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the CE marking or which reduces the visibility or the legibility of the CE marking.

Annotations:
Extent Information
E92

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

F89UK(NI) indication: active implantable medical devices24A

1

Where the CE marking referred to in regulation 24 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.

2

The UK(NI) indication must be affixed—

a

visibly, legibly and indelibly; and

b

before a relevant medical device is placed on the market in Northern Ireland.

3

The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 27.

F3963A

The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.

4

The UK(NI) indication must be affixed by the manufacturer.

5

Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.

6

No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service”;

F249UK marking of active implantable medical devices that come within the scope of this Part and other legislationE9325

Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied.

CE marking of active implantable medical devices that come within the scope of more than one DirectiveE5325

Where a relevant device comes within the scope of Directive 90/385 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, no person shall affix a CE marking to the device unless the relevant requirements of the other Directive are also satisfied, except where—

a

the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it;

b

the manufacturer chooses to follow the set of arrangements in Directive 90/385;

c

the marking of the device indicates that the device only satisfies the set of arrangements chosen by the manufacturer; and

d

the particulars of Directive 90/385, as published in the Official Journal of the F570European Union, are given in the documents, notices or instructions accompanying the device, and in a manner in which those particulars are accessible without it being necessary to destroy the packaging which keeps the device sterile.

Exemptions from regulations 22 and 24E2326

1

A relevant device being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of F511... these Regulations.

2

Regulation 24 shall not apply to a custom-made device or a device intended for clinical investigation.

3

Regulations 22 and 24 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a F436UK marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

F64

Regulations 22 and 24 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards or which is marked other than with a UK marking which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 22 and 24, may be placed on the market.

5

In paragraph (4), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 22 and 24, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.

Exemptions from regulations 22 and 24E6726

1

A relevant device being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of Directive 90/385 or these Regulations.

2

Regulation 24 shall not apply to a custom-made device or a device intended for clinical investigation.

3

Regulations 22 and 24 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

Annotations:
Extent Information
E67

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Procedures for affixing a F209UK marking to active implantable medical devicesE5727

A relevant device may bear a F160UK marking only if its manufacturer or F536their UK responsible person—

a

fulfils the applicable obligations imposed by—

i

Annex 2, or

ii

Annex 3, together with Annex 4 or 5;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of F304this Part that apply to it; F271...

c

ensures that the device meets the provisions of F304this Part which apply to it; F456and

F149d

fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).

Procedures for affixing a CE marking to active implantable medical devicesE4927

A relevant device may bear a CE marking only if its manufacturer or his authorised representative—

a

fulfils the applicable obligations imposed by—

i

Annex 2, or

ii

Annex 3, together with Annex 4 or 5;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 90/385 that apply to it; F676...

c

ensures that the device meets the provisions of Directive 90/385 which apply to it; F675and

F619d

fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).

Procedures for custom-made active implantable medical devicesE4328

No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or F109their UK responsible person—

a

has drawn up the statement containing the information required by Section 2.1 of Annex 6F479, read with Regulation (EU) No 722/2012;

b

has undertaken to keep available for the Secretary of State the documentation referred to in Section 3.1 of Annex 6;

c

takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex 6; and

d

keeps available for the Secretary of State the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b).

Procedures for custom-made active implantable medical devicesE728

No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or his authorised representative—

a

has drawn up the statement containing the information required by Section 2.1 of Annex 6F683, read with Regulation (EU) No 722/2012;

b

has undertaken to keep available for the Secretary of State the documentation referred to in Section 3.1 of Annex 6;

c

takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex 6; and

d

keeps available for the Secretary of State the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b).

Procedures for active implantable medical devices for clinical investigationsE7629

1

No person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in F454Great Britain unless, before he does so, the manufacturer of the device or F159their UK responsible person has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—

a

subject to paragraph (2), the statement required by Section 2.2 of Annex 6 F268, read with Regulation (EU) No 722/2012; and

b

an undertaking to keep available for the Secretary of State the documentation referred to in Section 3.1 and 3.2 of Annex 6.

F4181A

A manufacturer or their UK responsible person may request a meeting with the Secretary of State in advance of giving notice in writing to the Secretary of State pursuant to paragraph (1) in order to—

a

obtain advice on regulatory requirements relating to an intended clinical investigation; or

b

obtain a statistical review in relation to an intended clinical investigation.

2

The ethics committee opinion that forms part of the information required under Section 2.2 of Annex 6 need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or F159their UK responsible person as soon as it becomes available.

3

If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer F406or UK responsible person (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.

4

The Secretary of State may, in respect of notice in writing given by a manufacturer or F159their UK responsible person pursuant to paragraph (1), give written notice to the manufacturer or F159their UK responsible person—

a

if the ethics committee opinion required under Section 2.2 of Annex 6 is favourable, that the relevant device may be made available for the purposes of the intended investigation; or

b

if the ethics committee opinion required under Section 2.2 of Annex 6 is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.

5

A written notice pursuant to paragraph (4) may—

a

where appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;

b

at any time be withdrawn on grounds of public health or public policy by the Secretary of State.

6

Where a written notice pursuant to paragraph (4) in respect of a relevant device has been withdrawn by the Secretary of State—

a

further clinical use of the relevant device in the investigation is prohibited; and

b

no person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),

unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.

7

The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or F159their UK responsible person, shall—

a

take all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1, and the first paragraph of Section 3.2, of Annex 6;

b

keep available for the Secretary of State the information contained in the statement and the undertaking referred to in paragraph (1); and

c

authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation.

8

The grounds of public health or public policy referred to in paragraphs (3) and (5)(b) are met, amongst other reasons, if—

a

the manufacturer or F159their UK responsible person does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (7); or

b

the manufacturer or F159their UK responsible person does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1).

9

No person shall conduct a clinical investigation of a relevant device—

a

otherwise than in accordance with Annex 7; and

b

otherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (5)(a),

and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or F159their UK responsible person shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex 7.

F36410

The manufacturer, or their F472single UK responsible person, shall—

a

notify the Secretary of State of the end of the clinical investigation; and

b

provide justification where premature termination has resulted.

Procedures for active implantable medical devices for clinical investigationsE4729

1

No person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in F177Northern Ireland unless, before he does so, the manufacturer of the device or his authorised representative has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—

a

subject to paragraph (2), the statement required by Section 2.2 of Annex 6 F572, read with Regulation (EU) No 722/2012; and

b

an undertaking to keep available for the Secretary of State the documentation referred to in Section 3.1 and 3.2 of Annex 6.

2

The ethics committee opinion that forms part of the information required under Section 2.2 of Annex 6 need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or his authorised representative as soon as it becomes available.

3

If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer or authorised representative (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.

4

The Secretary of State may, in respect of notice in writing given by a manufacturer or his authorised representative pursuant to paragraph (1), give written notice to the manufacturer or his authorised representative—

a

if the ethics committee opinion required under Section 2.2 of Annex 6 is favourable, that the relevant device may be made available for the purposes of the intended investigation; or

b

if the ethics committee opinion required under Section 2.2 of Annex 6 is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.

5

A written notice pursuant to paragraph (4) may—

a

where appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;

b

at any time be withdrawn on grounds of public health or public policy by the Secretary of State.

6

Where a written notice pursuant to paragraph (4) in respect of a relevant device has been withdrawn by the Secretary of State—

a

further clinical use of the relevant device in the investigation is prohibited; and

b

no person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),

unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.

7

The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or his authorised representative, shall—

a

take all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1, and the first paragraph of Section 3.2, of Annex 6;

b

keep available for the Secretary of State the information contained in the statement and the undertaking referred to in paragraph (1); and

c

authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation.

8

The grounds of public health or public policy referred to in paragraphs (3) and (5)(b) are met, amongst other reasons, if—

a

the manufacturer or his authorised representative does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (7); or

b

the manufacturer or his authorised representative does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1).

9

No person shall conduct a clinical investigation of a relevant device—

a

otherwise than in accordance with Annex 7; and

b

otherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (5)(a),

and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or his authorised representative shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex 7.

F68810

The manufacturer, or their single authorised representative, shall—

a

notify the Secretary of State of the end of the clinical investigation; and

b

provide justification where premature termination has resulted.

Manufacturers etc. and conformity assessment procedures for active implantable medical devicesE4030

1

A manufacturer of a relevant device or, where applicable, F180their UK responsible person who is required to follow, or follows or has followed a conformity assessment procedure F229in the Annexes referred to in regulation 27(a) shall observe the manufacturer’s obligations set out in that procedure that apply to him.

2

A manufacturer of a relevant device or, where applicable, F330their UK responsible person shall, when following a conformity assessment procedure F253in the Annexes referred to in regulation 27(a), take account of the results of any assessment or verification operations which have been carried out F51... at an intermediate stage of manufacture of the device.

F3173

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4444

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4445

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturers etc. and conformity assessment procedures for active implantable medical devicesE130

1

A manufacturer of a relevant device or, where applicable, his authorised representative who is required to follow, or follows or has followed a conformity assessment procedure set out in Directive 90/385 shall observe the manufacturer’s obligations set out in that procedure that apply to him.

2

A manufacturer of a relevant device or, where applicable, his authorised representative shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 90/385 at an intermediate stage of manufacture of the device.

F6693

Except as provided in paragraphs (4) and (5), the manufacturer of a relevant device, who under their own name places devices on the market, in accordance with the procedure referred to in Article 9(2) of Directive 90/385, shall provide the Secretary of State with—

a

the address of their registered place of business;

b

a description of the devices concerned; and

c

details of the label and instructions for use that accompany each device.

4

Where the manufacturer of a relevant device places a device on the market under their own name, but does not have a registered place of business in F203a relevant state, the manufacturer shall—

a

designate a single authorised representative; and

b

ensure that the authorised representative has a registered place of business in F203a relevant state.

5

The authorised representative referred to in paragraph (4) shall provide the competent authority of F484the relevant state in which they have their registered place of business with the information referred to in paragraph (3) above.

F44Obligations in Part III which are met by complying with obligations in Directive 90/38530A

1

In this regulation—

a

“the Directive” means Directive 90/385 F309as it had effect on 25 May 2021 and any reference to an Article or Annex is a reference to that Article or Annex in the Directive F419...;

b

“Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it has effect in EU Law;

c

“CE marking” means the CE marking required by Article 12 and shown in Annex 9;

d

“harmonised standard” is to be construed in accordance with Article 5.

2

Where paragraph (3) applies regulations 22, 24(1) to (4), 25 and 27 are treated as being satisfied.

3

This paragraph applies where, before placing a relevant device other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—

a

ensures—

i

that the device meets the essential requirements set out in Annex I and, where applicable, Regulation (EU) 722/2012, which apply to it; or

ii

that paragraphs (8) and (9) apply;

b

ensures that the relevant conformity assessment procedure that applies to the device, where the device is a device other than those which are custom-made or intended for clinical investigations, has been carried out in accordance with Article 9;

F447ba

ensures that the certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;

c

ensures that the documentation required by the relevant conformity assessment procedure is drawn up;

d

ensures that the technical and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English;

e

affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes 2, 3, 4 or 5;

f

F11has drawn up before 26 May 2021 an EU Declaration of Conformity in accordance with Article 9; and

g

ensures that the declaration of conformity is prepared in or translated into English.

4

Where paragraph (5) applies, regulations 25 and 28 are treated as being satisfied.

5

This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—

a

has drawn up a statement in English containing the information required by Section 1 and specified in Section 2.1 of Annex 6, read with Regulation 722/2012;

b

has undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow an assessment of conformity of the device with the requirements of the Directive;

c

undertakes to the Secretary of State—

i

to comply with Section 3.1 of Annex 6;

ii

to keep all documentation required by Annex 6 for the period specified in Section 4 of Annex 6; and

iii

to pass on the statement mentioned in sub-paragraph (a) with the custom-made device so that it may be made available to the patient on request.

6

Where paragraph (7) applies, regulations, 22 and 29 are treated as being satisfied.

7

This paragraph applies where, before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—

a

has provided the Secretary of State with the relevant written notice which must be in English in the form of the statement required by Section 2.2 of Annex 6;

b

has provided an undertaking to keep available for five years the documentation referred to in Section 3.1 and 3.2 of Annex 6; and

c

has taken all necessary measures to ensure that the manufacturing process for the device produces devices in accordance with the documentation referred to in Section 3.2 of Annex 6.

8

Where paragraph (9) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4).

9

This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.

10

For the purpose of this regulation in regulations 24(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.

F306Approved bodies and the conformity assessment procedures for active implantable medical devicesE3231

1

F182An approved body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

a

take account of the results of any assessment or verification operations which have been carried out in accordance with F385this Part at an intermediate stage of manufacture of the device; and

b

lay down, by common accord with the manufacturer or F104their UK responsible person, the time limits for completion of the assessment and verification operations referred to in Annex 2 or 3.

2

Where F25an approved body takes a decision in accordance with F325Annex 2, 3 or 5, they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.

3

F433Where an approved body and a manufacturer or the manufacturer’s UK responsible person have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or F18the manufacturer’s UK responsible person, extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.

UK notified bodies and the conformity assessment procedures for active implantable medical devicesE6131

1

A UK notified body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

a

take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 90/385 at an intermediate stage of manufacture of the device; and

b

lay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annex 2 or 3.

2

Where a UK notified body takes a decision in accordance with F667Annex 2, 3 or 5, they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.

3

Where a UK notified body and a manufacturer or his authorised representative have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or his authorised representative, extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.

PART IVIn Vitro Diagnostic Medical Devices

Interpretation of Part IVE8632

1

In this Part F3...—

  • “accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not—

    1. a

      itself an in vitro diagnostic medical device;

    2. b

      an invasive sampling medical device; or

    3. c

      a medical device which is directly applied to the human body for the purpose of obtaining a specimen;

  • “calibration and control material” means any substance, material or article intended by its manufacturer either to establish measurement relationships or to verify the performance characteristics of a relevant device in conjunction with the intended use of that device;

  • F155“common technical specification” means a technical specification set out in the Annex to Commission Decision 2002/364/EC (as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act) for a relevant device referred to in a list in Annex II;

  • “device for self-testing” means anin vitro diagnostic medical device which is intended by its manufacturer to be able to be used by a member of the public in a home environment; and

  • “relevant device” shall be construed in accordance with regulation 33(1);

2

In this Part F3..., a reference to a numbered article or Annex is to the article or Annex of Directive 98/79 bearing that number.

Interpretation of Part IVE3732

1

In this Part F601...—

  • “accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not—

    1. a

      itself an in vitro diagnostic medical device;

    2. b

      an invasive sampling medical device; or

    3. c

      a medical device which is directly applied to the human body for the purpose of obtaining a specimen;

  • “calibration and control material” means any substance, material or article intended by its manufacturer either to establish measurement relationships or to verify the performance characteristics of a relevant device in conjunction with the intended use of that device;

  • “common technical specification” means a technical specification for a relevant device referred to in a list in Annex II which has been adopted in accordance with the procedure set out in article 7(2) and published in the Official Journal of the F686European Union;

  • “device for self-testing” means anin vitro diagnostic medical device which is intended by its manufacturer to be able to be used by a member of the public in a home environment; and

  • “relevant device” shall be construed in accordance with regulation 33(1);

2

In this Part F601..., a reference to a numbered article or Annex is to the article or Annex of Directive 98/79 bearing that number.

Scope of Part IV33

1

The requirements of this Part in respect of relevant devices apply in respect ofin vitro diagnostic medical devices F481(including coronavirus test devices) and accessories to such devices, except for—

a

products manufactured and used within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity; F358and

b

F248devices that come within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

i

the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and

ii

the manufacturer chooses to follow the set of arrangements in the other Directive.

2

The requirements of this Part in respect of devices for performance evaluation do not apply in respect of—

a

products manufactured and used only within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity; F142and

b

F252devices that come within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

i

the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and

ii

the manufacturer chooses to follow the set of arrangements in the other Directive.

F222Registration etc. of persons placing in vitro diagnostic medical devices on the market33A

1

No person may place a relevant device on the market in accordance with this Part unless that person—

a

is established in Great Britain; and

b

has complied with paragraph (2).

2

A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—

a

where—

i

that person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;

ii

that person is the manufacturer of that device and is based outside the United Kingdom, the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; or

iii

that person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;

b

that person supplies the Secretary of State with—

i

a description of the relevant device; and

ii

the relevant information in paragraph (4); and

c

that person pays to the Secretary of State the relevant fee in accordance with regulation 53.

2A

The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

3

The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—

a

ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

b

keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

c

in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

d

where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access;

e

where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;

f

cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

g

immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;

h

if the manufacturer acts contrary to its obligations under these Regulations—

i

terminate the legal relationship with the manufacturer; and

ii

inform the Secretary of State and, if applicable, the relevant approved body of that termination.

4

In this regulation “relevant information” means—

a

in relation to a new relevant device, a statement indicating that the device is a new relevant device;

b

if the device consists wholly or partly of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and analytes;

c

if the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications;

d

in relation to devices in a list in Annex II and devices for self-testing—

i

all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex 1;

ii

if requested by the Secretary of State, the labelling and instructions for use for when the device is placed on the market or put into service;

e

in relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I.

5

Within two years of the placing of a new relevant device on the market, the Secretary of State may, where the Secretary of State considers it justified, request a report relating to the experience gained with the device subsequent to it being placed on the market.

6

In this regulation a device is a “new relevant device” if—

a

there has been no such device continuously available on the United Kingdom or EEA market during the previous three years for the relevant analyte or other parameter; or

b

use of the device has involved analytical technology not continuously used in connection with a given analyte or other parameter on the United Kingdom or EEA market during the previous three years.

7

In paragraph (3)—

a

the references to “technical documentation” are to be construed in accordance with Annexes III to VIII;

b

the references to “declaration of conformity” are to be construed in accordance with Annexes III, IV, V and VII.

Essential requirements for in vitro diagnostic medical devices34

1

Subject to regulation 39, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it.

2

Subject to regulation 39, no person shall supply a relevant device—

a

if that supply is also a placing on the market or putting into service of that device; or

b

in circumstances where that device has been placed on the market or put into service, unless that device meets those essential requirements set out in Annex I which apply to it.

F43Approval requirement for coronavirus test devices34A

1

Subject to regulations F70734B to 34D, 39(1) and 39A, no person other than the Secretary of State may place on the market or put into service a coronavirus test device, unless—

a

the Secretary of State has approved it in accordance with regulation 38A(5); and

b

the approval remains valid in accordance with regulation 38A(6).

2

Subject to regulations F70834B to 34D, 39(1) and 39A, no person other than the Secretary of State may supply a coronavirus test device—

a

if that supply is also a placing on the market or putting into service of that device; or

b

in circumstances where that device has been placed on the market or put into service,

unless the Secretary of State has approved it in accordance with regulation 38A(5) and the approval remains valid in accordance with regulation 38A(6).

3

The requirements in paragraphs (1) and (2) are without prejudice to the other requirements of this Part.

Public sector use of coronavirus test devices34B

1

Regulation 34A(1) does not apply in relation to a coronavirus test device that is placed on the market or put into service only for use by—

a

the Secretary of State;

b

a devolved public health body; or

c

a health service body supplied pursuant to an existing contract.

2

Regulation 34A(2) does not apply in relation to a coronavirus test device that is supplied to—

a

the Secretary of State;

b

a devolved public health body; or

c

a health service body pursuant to an existing contract.

3

In this regulation—

  • “a devolved public health body” is—

    1. a

      in Wales, Welsh Ministers or Public Health Wales National Health Service Trust;

    2. b

      in Scotland, Scottish Ministers;

    3. c

      in Northern Ireland, the Department of Health in Northern Ireland;

  • “an existing contract” is a contract entered into before the coming into force of regulation 34A;

  • “a health service body” is—

    1. a

      an NHS body as defined in section 275 of the National Health Service Act 2006 or in section 206 of the National Health Service (Wales) Act 2006;

    2. b

      a body listed in section 17A(2)(a) to (c) or (e) of the National Health Service (Scotland) Act 1978; or

    3. c

      a health and social care body as defined in section 1(5)(a) to (e) of the Health and Social Care (Reform) Act (Northern Ireland) 2009.

Transitional provisions for coronavirus test devices34C

1

The requirements in regulation 34A do not apply in respect of any period before 1st September 2021.

2

A person may place on the market, put into service or supply a coronavirus test device from 1st September 2021 until the end of 31st October 2021 if—

a

that person has made an application to the Secretary of State in respect of that device, in accordance with regulation 38A; or

b

that person is not—

i

the manufacturer of the device,

ii

a person acting as the manufacturer’s UK responsible person appointed for the purposes of regulation 33A or under regulation 44A, or

iii

a person acting as the manufacturer’s authorised representative in Northern Ireland in accordance with regulation 44.

F689Exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/110734D

Regulation 34A does not apply in Northern Ireland—

a

in relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746 and the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107;

b

after 24 July 2024, in relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746.

Determining compliance of in vitro diagnostic medical devices with relevant essential requirementsE5235

1

In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

2

In order to meet the essential requirements set out in Section 8 of Part B of Annex I, the information to be provided under that Section must be in English F467... .

3

A relevant device shall be presumed to comply with an essential requirement if it conforms as respects that requirement to a relevant F417designated standard.

4

A relevant device shall be treated as complying with an essential requirement in respect of which there is an applicable common technical specification only if it is in conformity with that specification or, if for duly justified reasons the manufacturer has not complied with that specification, an equivalent or higher specification.

Determining compliance of in vitro diagnostic medical devices with relevant essential requirementsE8835

1

In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

2

In order to meet the essential requirements set out in Section 8 of Part B of Annex I, the information to be provided under that Section must be in English if the device may reach a final user in F161Northern Ireland, unless—

a

the Secretary of State, to the extent that Directive 98/79 allows him to do so, has authorised the use of another Community language or more than one other Community language; or

b

the relevant device is a device for self-testing, in which case the instructions for use and the label must include a translation into the official language of any member State of the Community in which the device reaches a final user.

3

A relevant device shall be presumed to comply with an essential requirement if it conforms as respects that requirement to a relevant national standard.

4

A relevant device shall be treated as complying with an essential requirement in respect of which there is an applicable common technical specification only if it is in conformity with that specification or, if for duly justified reasons the manufacturer has not complied with that specification, an equivalent or higher specification.

F19UK marking of in vitro diagnostic medical devicesE3536

1

Subject to regulation 39, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device bears a F395UK marking which—

a

meets the requirements set out in F426Annex 2 of Regulation 765/2008;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant F208approved body or conformity assessment body identification number for that device.

2

Subject to regulation 39, no person shall supply a relevant device unless, where practical and appropriate, that device bears a F395UK marking which—

a

meets the requirements set out in F426Annex 2 of Regulation 765/2008;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant F208approved body or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service or if that supply is of a device that has been placed on the market or put into service.

3

Subject to regulation 39, no person shall place on the market or put into service a relevant device unless a F395UK marking, meeting the requirements set out in F426Annex 2 of Regulation 765/2008, appears on—

a

any sales packaging for that device; and

b

the instructions for use for that device,

and that F395UK marking is accompanied by any relevant F208approved body or conformity assessment body identification number for that device.

4

Subject to regulation 39, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a F395UK marking, meeting the requirements set out in F426Annex 2 of Regulation 765/2008, appears on—

a

any sales packaging for that device; and

b

the instructions for use for that device,

and that F395UK marking is accompanied by any relevant F208approved body or conformity assessment body identification number for that device.

5

Subject to regulation 39, no person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

a

a relevant device;

b

the instructions for use for a relevant device; or

c

any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the F395UK marking or which reduces the visibility or the legibility of the F395UK marking.

F3356

In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—

a

as not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and

b

as allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).

CE marking of in vitro diagnostic medical devicesE6836

1

Subject to regulation 39, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device bears a CE marking which—

a

meets the requirements set out in Annex X;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant notified body or conformity assessment body identification number for that device.

2

Subject to regulation 39, no person shall supply a relevant device unless, where practical and appropriate, that device bears a CE marking which—

a

meets the requirements set out in Annex X;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant notified body or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service or if that supply is of a device that has been placed on the market or put into service.

3

Subject to regulation 39, no person shall place on the market or put into service a relevant device unless a CE marking, meeting the requirements set out in Annex X, appears on—

a

any sales packaging for that device; and

b

the instructions for use for that device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

4

Subject to regulation 39, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a CE marking, meeting the requirements set out in Annex X, appears on—

a

any sales packaging for that device; and

b

the instructions for use for that device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

5

Subject to regulation 39, no person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

a

a relevant device;

b

the instructions for use for a relevant device; or

c

any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the CE marking or which reduces the visibility or the legibility of the CE marking.

Annotations:
Extent Information
E68

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

F283UK(NI) indication: in vitro diagnostic medical devices36A

1

Where the CE marking referred to in regulation 36 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.

2

The UK(NI) indication must be affixed—

a

visibly, legibly and indelibly; and

b

before a relevant medical device is placed on the market in Northern Ireland.

3

The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 36.

F2723A

The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.

4

The UK(NI) indication must be affixed by the manufacturer.

5

Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.

6

No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service.

F399UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislationE1337

Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied.

CE marking of in vitro diagnostic medical devices that come within the scope of more than one DirectiveE8137

Where a relevant device comes within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, no person shall affix a CE marking to the device unless the relevant requirements of the other Directive are satisfied, except where—

a

the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it;

b

the manufacturer chooses to follow the set of arrangements in Directive 98/79;

c

the marking of the device indicates that the device only satisfies the set of arrangements chosen by the manufacturer; and

d

the particulars of Directive 98/79, as published in the Official Journal of the F569European Union, are given in the documents, notices or instructions accompanying the device.

In vitro diagnostic medical devices not ready for use38

Subject to regulation 39, no person shall—

a

put into service a relevant device;

b

supply a relevant device—

i

if that supply is also a putting into service of that device, or

ii

in circumstances where that device has been placed on the market or put into service,

which is not ready for use.

F28Applications for approval of coronavirus test devices38A

1

A person may make an application to the Secretary of State under this regulation for approval of a coronavirus test device.

2

An application must include such information as the Secretary of State may require for the purposes of exercising their functions under—

a

paragraph (5); and

b

regulation 38C.

3

An application must be made through the gov.uk website.

4

The Secretary of State may treat an application made before the coming into force of this regulation as an application made under this regulation, if it meets the requirements of paragraph (2).

5

The Secretary of State must approve a coronavirus test device if the Secretary of State is satisfied on the basis of the information contained in the application that the coronavirus test device meets the requirements of regulation 38B.

6

An approval granted under paragraph (5) is valid for a period of 5 years, beginning with the day on which it is granted.

7

Nothing in this regulation shall be taken to prevent—

a

the Secretary of State;

b

a weights and measures authority in Great Britain; or

c

a district council in Northern Ireland,

from exercising a duty under regulation 61 to enforce these Regulations.

Performance requirements for coronavirus test devices38B

1

The requirements that a coronavirus test device must meet for the purposes of regulation 38A(5) are set out in paragraphs (2) to (6).

2

A coronavirus test device must be able to be put into service in accordance with this Part.

3

A coronavirus test device that is an antigen test must have—

a

a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 60%;

b

a level of specificity, using a 95% two-sided confidence interval, that is entirely above 93%.

4

A coronavirus test device that is a direct molecular test must have—

a

a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 70%;

b

a level of specificity, using a 95% two-sided confidence interval, that is entirely above 93%.

5

A coronavirus test device that is an extracted molecular test must have—

a

a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 93%;

b

a level of specificity, using a 95% two-sided confidence interval, that is entirely above 97%.

6

Where a coronavirus test device is also intended to detect the presence of anything other than a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the requirements in paragraphs (2) to (5) apply only in relation to its performance in detecting the presence of that viral antigen or viral ribonucleic acid (RNA).

7

In this regulation and in regulation 38C—

  • “antigen test” means an in vitro diagnostic medical device for the detection of the presence of a viral antigen specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

  • “direct molecular test” means an in vitro diagnostic medical device which—

    1. a

      is for the detection of the presence of viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and

    2. b

      does not use a preliminary step of purification and concentration;

  • “extracted molecular test” means an in vitro diagnostic medical device which—

    1. a

      is for the detection of the presence of viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and

    2. b

      uses a preliminary step of purification and concentration;

  • “sensitivity”, in relation to a coronavirus test device, means the proportion of true positives that are correctly identified by the test, calculated using the equation—

  • “specificity”, in relation to a coronavirus test device, means the proportion of true negatives that are correctly identified by the test, calculated using the equation—

Register of approved coronavirus test devices38C

1

The Secretary of State must establish a register of coronavirus test devices which the Secretary of State has approved in accordance with regulation 38A.

2

The Secretary of State must publish the register on the gov.uk website.

3

The register must contain the following information in respect of each coronavirus test device—

a

the name and address of the registered place of business of the person who made the application under regulation 38A;

b

if the person who made the application was not the manufacturer, the name and address of the registered place of business of the manufacturer;

c

the country in which the manufacturer is established;

d

the name and address of the registered place of business of the UK responsible person or the manufacturer’s authorised representative having a registered place of business in Northern Ireland, if there is one in respect of the device;

e

the name and description of the coronavirus test device;

f

the date and version number of the instructions for use included in the application;

g

whether the coronavirus test device is an antigen test, a direct molecular test, or an extracted molecular test;

h

the date on which the coronavirus test device was approved in accordance with regulation 38A and the date on which that approval ceases to be valid.

4

The register may contain such other information relating to the coronavirus test device and its intended use as the Secretary of State considers appropriate.

Exemptions from F300this PartE8539

1

A relevant device being shown at a trade fair, exhibition, scientific gathering or technical gathering is not being placed on the market or put into service if—

a

the device is not used on any specimen taken from the participants; and

b

a visible sign clearly indicates that the device cannot be marketed or put into service until it complies with the requirements of F65... these Regulations.

2

Regulations 34, 36 and 38 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a F411UK marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

F3753

Regulations 34 and 36 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards or which is marked other than with a UK marking which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 34 and 36, may be placed on the market.

4

In paragraph (3), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 34 and 36, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.

Exemptions from regulations 34, 36 and 38E3839

1

A relevant device being shown at a trade fair, exhibition, scientific gathering or technical gathering is not being placed on the market or put into service if—

a

the device is not used on any specimen taken from the participants; and

b

a visible sign clearly indicates that the device cannot be marketed or put into service until it complies with the requirements of Directive 98/79 or these Regulations.

2

Regulations 34, 36 and 38 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

Annotations:
Extent Information
E38

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

F88Exemptions for coronavirus test devices39A

1

Regulation 34A does not apply where, in circumstances which give rise to a need to protect the public from a risk of serious harm to health, the Secretary of State—

a

has decided to permit, where appropriate for a specified period, the placing on the market or putting into service of a particular coronavirus test device or coronavirus test devices of a particular class or description that has not been approved under regulation 38A(5); and

b

has not withdrawn that permission.

2

The Secretary of State may give permission under paragraph (1) subject to such conditions as are set out in a protocol published by the Secretary of State.

3

If the Secretary of State publishes a protocol for the purpose of paragraph (2), the protocol must specify the period of time for which it has effect.

4

The Secretary of State may withdraw or amend a protocol published under paragraph (2).

Procedures for affixing a F554UK marking to in vitro diagnostic medical devicesE1840

1

A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a F278UK marking only if its manufacturer or F118their UK responsible person—

a

fulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;

b

declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of F241this Part which apply to it; and

c

ensures that the device meets the provisions of F241this Part which apply to it.

2

A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a F278UK marking only if its manufacturer or F118their UK responsible person—

a

fulfils the applicable obligations imposed by—

i

Sections 1 to 6 of Annex III,

ii

Annex IV, or

iii

Annex V and either Annex VI or Annex VII;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of F241this Part which apply to it; and

c

ensures that the device meets the provisions of F241this Part which apply to it.

3

A relevant device referred to in List A in Annex II may bear a F278UK marking only if its manufacturer or F118their UK responsible person—

a

fulfils the applicable obligations imposed by—

i

Annex IV, or

ii

Annexes V and VII;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of F241this Part which apply to it; and

c

ensures that the device meets the provisions of F241this Part which apply to it.

4

A relevant device referred to in List B in Annex II may bear a F278UK marking only if its manufacturer or F118their UK responsible person—

a

fulfils the applicable obligations imposed by—

i

Annex IV,

ii

Annexes V and VI, or

iii

Annexes V and VII;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of F241this Part which apply to it; and

c

ensures that the device meets the provisions of F241this Part which apply to it.

Procedures for affixing a CE marking to in vitro diagnostic medical devicesE2040

1

A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a CE marking only if its manufacturer or his authorised representative—

a

fulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;

b

declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 98/79 which apply to it; and

c

ensures that the device meets the provisions of Directive 98/79 which apply to it.

2

A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

a

fulfils the applicable obligations imposed by—

i

Sections 1 to 6 of Annex III,

ii

Annex IV, or

iii

Annex V and either Annex VI or Annex VII;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

c

ensures that the device meets the provisions of Directive 98/79 which apply to it.

3

A relevant device referred to in List A in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

a

fulfils the applicable obligations imposed by—

i

Annex IV, or

ii

Annexes V and VII;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

c

ensures that the device meets the provisions of Directive 98/79 which apply to it.

4

A relevant device referred to in List B in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

a

fulfils the applicable obligations imposed by—

i

Annex IV,

ii

Annexes V and VI, or

iii

Annexes V and VII;

b

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

c

ensures that the device meets the provisions of Directive 98/79 which apply to it.

Annotations:
Extent Information
E20

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devicesE3941

1

A manufacturer of a relevant device or, where applicable, F83their UK responsible person who is required to follow, or follows or has followed a conformity assessment procedure set out in F543this Part shall observe the manufacturer’s obligations set out in that procedure F75that apply to the manufacturer or, as the case may be, their UK responsible person.

2

A manufacturer of a relevant device or, where applicable, F83their UK responsible person shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with F543this Part at an intermediate stage of manufacture of the device.

3

A manufacturer or, where applicable, F83their UK responsible person shall, in respect of any relevant device which the manufacturer has placed on the market or put into service, keep available for inspection by the Secretary of State—

a

the declaration of conformity for that device;

b

the technical documentation referred to in Annexes III to VIII relating to that device; and

c

the decisions, reports and certificates of F486approved bodies relating to that device,

for a period ending five years after the manufacture of the last product.

4

A person who in the course of manufacturing relevant devices or devices for performance evaluation removes, collects, or uses tissues, cells or substances of human origin shall, in the course of removing, collecting or using those tissues, cells or substances act in accordance with the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine M2.

F3275

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devicesE4441

1

A manufacturer of a relevant device or, where applicable, his authorised representative who is required to follow, or follows or has followed a conformity assessment procedure set out in Directive 98/79 shall observe the manufacturer’s obligations set out in that procedure that apply to him.

2

A manufacturer of a relevant device or, where applicable, his authorised representative shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 98/79 at an intermediate stage of manufacture of the device.

3

A manufacturer or, where applicable, his authorised representative shall, in respect of any relevant device which the manufacturer has placed on the market or put into service, keep available for inspection by the Secretary of State—

a

the declaration of conformity for that device;

b

the technical documentation referred to in Annexes III to VIII relating to that device; and

c

the decisions, reports and certificates of notified bodies relating to that device,

for a period ending five years after the manufacture of the last product.

4

A person who in the course of manufacturing relevant devices or devices for performance evaluation removes, collects, or uses tissues, cells or substances of human origin shall, in the course of removing, collecting or using those tissues, cells or substances act in accordance with the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine M10.

5

Until the European databank referred to in article 12 has been established, the manufacturer or, where applicable, his authorised representative shall, in respect of any relevant device which the manufacturer has placed on the market F464in Northern Ireland, provide the Secretary of State with the data referred to in article 12(1)(a), and that data shall be provided in English.

F565Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices42

1

F555An approved body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

a

take account of the results of any assessment or verification operations which have been carried out F561... at an intermediate stage of manufacture of the device;

b

take account of any relevant information relating to the characteristics and performance of that device, F560...; and

c

lay down, by common accord with the manufacturer or F557their UK responsible person, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII.

2

Where F556an approved body takes a decision in accordance with Annex III, IV, or V, they shall specify the period of validity of the decision, which, initially, shall be a period of not more than 5 years.

3

Where F562an approved body and a manufacturer or F559their UK responsible person have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or F559their UK responsible person, extend the period of validity of the decision for further periods of up to 5 years, each such period commencing on the expiry of the previous period.

UK notified bodies and the conformity assessment procedures for in vitro diagnostic medical devices42

1

A UK notified body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

a

take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 98/79 at an intermediate stage of manufacture of the device;

b

take account of any relevant information relating to the characteristics and performance of that device, including in particular the results of any relevant tests and verification relating to that device already carried out before 7th June 2000; and

c

lay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII.

2

Where a UK notified body takes a decision in accordance with Annex III, IV, or V, they shall specify the period of validity of the decision, which, initially, shall be a period of not more than 5 years.

3

Where a UK notified body and a manufacturer or his authorised representative have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or his authorised representative, extend the period of validity of the decision for further periods of up to 5 years, each such period commencing on the expiry of the previous period.

Devices for performance evaluationE2443

No person shall supply a device for performance evaluation (if that supply is also a making available of the device) unless the manufacturer or F434their UK responsible person—

a

has drawn up a statement containing the information required by Section 2 of Annex VIII and keeps that statement available for the Secretary of State for a minimum period of five years after the end of the performance evaluation;

b

ensures that—

i

the device conforms with the documentation mentioned in the said section 2, and

ii

the relevant requirements of F197these Regulations are complied with as respects that device; and

c

undertakes to keep available, and keeps available, for the Secretary of State, for a minimum period of five years after the end of the performance evaluation, documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations.

Devices for performance evaluationE3443

No person shall supply a device for performance evaluation (if that supply is also a making available of the device) unless the manufacturer or his authorised representative—

a

has drawn up a statement containing the information required by Section 2 of Annex VIII and keeps that statement available for the Secretary of State for a minimum period of five years after the end of the performance evaluation;

b

ensures that—

i

the device conforms with the documentation mentioned in the said section 2, and

ii

the relevant requirements of the Directive are complied with as respects that device; and

c

undertakes to keep available, and keeps available, for the Secretary of State, for a minimum period of five years after the end of the performance evaluation, documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations.

Annotations:
Extent Information
E34

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

F366F103Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation44

1

Paragraph (2) applies—

a

in relation to relevant devices that are Annex II devices or devices for self-testing, to—

i

a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland, or makes available for performance evaluation, any relevant device;

F709ii

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iii

a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;

iv

a manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;

b

in relation to relevant devices other than Annex II devices or devices for self-testing, to—

i

a manufacturer who places a device on the Northern Ireland market, or makes such a device available for performance evaluation, and has a registered place of business in Northern Ireland;

ii

an authorised representative with a registered place of business in Northern Ireland.

2

For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—

a

inform the Secretary of State of the address of their registered place of business; and

b

supply the Secretary of State with—

i

a description of each category of device concerned;

ii

the relevant information in paragraph (7);

F710c

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

d

in the case of an authorised representative, supply the Secretary of State with—

i

written evidence that they have been designated as an authorised representative;

ii

details of the person who has so designated them; and

iii

where the person placing the devices concerned on the market, or making them available for performance evaluation, is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market, or making them available for performance evaluation;

e

inform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.

3

The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of any of the dates specified in paragraph (4) that apply in respect of a particular case.

4

The obligations in paragraph (2) begin to apply—

a

where a device is being placed on the market by a manufacturer with a registered place of business in Northern Ireland or by a person who has designated an authorised representative with a registered place of business in Northern Ireland, on 1st January 2021;

b

in circumstances other than those described in sub-paragraph (a)—

i

in the case of a relevant device that is a List A device, on 1st May 2021;

ii

in the case of a relevant device that is a device for self-testing, on 1st September 2021; and

iii

in the case of a relevant device that is a List B device, on 1st September 2021.

F7115

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7126

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

In this regulation “relevant information” means—

a

in relation to a new relevant device, a statement indicating that the device is a new relevant device;

b

if the device consists wholly or partly of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and analytes;

c

if the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications;

d

in relation to devices in a list in Annex II and devices for self-testing—

i

all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex 1;

ii

if requested by the Secretary of State, the labelling and instructions for use for when the device is placed on the market or put into service;

e

in relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I.

8

Within two years of the placing of a new relevant device on the market, the Secretary of State may, where the Secretary of State considers it justified, request a report relating to the experience gained with the device subsequent to it being placed on the market.

9

In paragraphs (7) and (8) a device is a “new relevant device” if—

a

there has been no such device continuously available on the United Kingdom or EEA market during the previous three years for the relevant analyte or other parameter; or

b

use of the device has involved analytical technology not continuously used in connection with a given analyte or other parameter on the United Kingdom or EEA market during the previous three years.

F713F76Obligations in Part IV which are met by complying with obligations in Directive 98/7944ZA

1

In this regulation—

a

any reference to an Article or Annex is a reference to that Article or Annex in Directive 98/79 as F22it had effect on 25 May 2022;

b

“Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it applies in the European Union;

c

“CE marking” means the CE marking required by Article 16 and shown in Annex X;

d

“harmonised standard” is to be construed in accordance with Article 5.

2

Where paragraph (3) applies regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied.

3

F405Subject to to paragraph (3A), this paragraph applies where, before placing a relevant device on the market, the manufacturer—

a

ensures—

i

that the device meets the essential requirements set out in Annex I and, where applicable, Regulation (EU) 722/2012, which apply to it; or

ii

that paragraphs (6) and (7) apply;

b

ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 9;

F421ba

ensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 110(2) of Regulation (EU) 2017/746;

c

ensures that the documentation required by the relevant conformity assessment procedure is drawn up;

d

ensures that the technical and other relevant documentation required by a relevant conformity assessment procedure is prepared in or translated into English;

e

affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes III, IV, V, VI or VII;

f

F153has drawn up before 26 May 2022 an EU Declaration of Conformity in accordance with Article 9;

g

ensures that the declaration of conformity is prepared in or translated into English.

F623A

Paragraph (3) only applies to a relevant device for which the conformity assessment procedure under Article 9 did not require the involvement of a notified body, if the conformity assessment procedure for that device under Article 48 of Regulation (EU) 2017/746 would require the involvement of a notified body.

4

Where paragraph (5) applies, regulation 43 is treated as being satisfied.

5

This paragraph applies where before a relevant device intended for performance evaluation is made available in Great Britain for the purpose of a performance evaluation, the manufacturer—

a

has supplied the relevant written notice which must be in English in the form required by Sections 1 and 2 of Annex VIII;

b

has provided an undertaking to the Secretary of State to keep available the documentation required by Annex VIII for the period specified in Section 3 of Annex VIII;

c

has taken all necessary measures to ensure that the manufacturing process for the device produces devices in accordance with the documentation referred to in the first paragraph of Section 3 of Annex VIII.

6

Where paragraph (7) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirements referred to in regulation 35(3) and (4).

7

This paragraph applies where—

a

a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard; or

b

a relevant device is in conformity with a common technical specification.

8

For the purpose of this regulation in regulations 36(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.

F76Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/74644ZB

1

In this regulation—

a

any reference to an Article or Annex is a reference to that Article or Annex in Regulation (EU) 2017/746 as it has effect in EU law;

b

“CE marking” means the CE marking required by Article 18 and presented in Annex V;

c

“harmonised standard” has the meaning given in Article 2(73);

d

“sponsor” has the meaning given in Article 2(57).

2

Where paragraph (3) applies, regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied.

3

This paragraph applies where, before placing a relevant device on the market, the manufacturer—

a

ensures—

i

that the device meets the general safety and performance requirements in Annex I which apply to it; or

ii

that paragraphs (6) and (7) apply;

b

ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 48;

F532ba

ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn;

c

ensures that the documentation required by the relevant conformity assessment procedure is drawn up;

d

ensures that the technical documentation required by Annexes II and III and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English;

e

affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedures set out in Annexes IX, X and XI;

f

draws up an EU declaration of conformity in accordance with Article 17; and

g

ensures that the declaration of conformity is prepared in or translated into English.

4

Where paragraph (5) applies, regulation 43 is treated as being satisfied.

5

This paragraph applies where, before a person supplies or makes available a device falling within Part IV for the purposes of performance evaluation, the sponsor of the performance evaluation—

a

has been able to provide the Secretary of State with the required notice in the form of the application required by Chapter I of Annex XIV in English;

b

has been able to provide the Secretary of State with an undertaking to keep available information contained in the application in accordance with Chapter II of Annex XIV.

6

Where paragraph (7) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirements referred to in regulation 35(3) and (4).

7

This paragraph applies where—

a

a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard; or

b

a relevant device is in conformity with a common technical specification.

8

For the purpose of this regulation, in regulations 36(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.

PART VF452Notified BodiesF452Approved Bodies, Conformity Assessment Bodies and Marking of Products

Annotations:
Amendments (Textual)

F72Interpretation of Part V44A

In this Part, “medical device” means a device that is a “relevant device” for the purposes of Part II, III or IV.

F369Meaning of approved body and UK notified bodyA45

1

An approved body is a conformity assessment body which—

a

has been designated by the Secretary of State pursuant to the procedure set out in regulation 45 (designation etc. of approved bodies); or

b

immediately before IP completion day was a UK notified body in respect of which the Secretary of State has taken no action under regulation 45(5) to withdraw a designation.

2

In this regulation—

  • “UK notified body” means a body which the Secretary of State had before IP completion day notified to the European Commission in accordance with Article 3(7) of Commission Implementing Regulation (EU) 920/2013 or under Article 15 of Directive 98/79.”.

Designation etc. of F519approved bodiesE2545

1

The Secretary of State may designate for the purposes of F280these Regulations any corporate or other body as a body which is to carry out any of the tasks of F36an approved body, and, if he so designates a body (referred to in these Regulations as F431an “approved body”), he shall designate the tasks which it is to carry out.

2

A body may be designated under paragraph (1) as a body which is to carry out tasks of F107an approved body only if—

a

in so far as it is to be designated as a body which is to carry out tasks included in F92Part III, it is a body in respect of which the criteria for the designation of F8approved bodies set out in Annex 8 of Directive 90/385F389, read with Regulation (EU) No 722/2012, are met;

b

in so far as it is to be designated as a body which is to carry out tasks included in F354Part II, it is a body in respect of which the criteria for the designation of F299approved bodies set out in Annex XI of Directive 93/42F91, read with F512Regulation (EU) No 722/2012, are met;

c

in so far as it is to be designated as a body which is to carry out tasks included in F504Part IV, it is a body in respect of which the criteria for the designation of F437approved bodies set out in Annex IX of Directive 98/79 are met; and

d

in so far as it needs to be able to fulfil the functions of an importing Party arising out of F312a mutual recognition agreement, it is able to do so.

3

The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

4

The Secretary of State may vary the tasks that F329an approved body may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

5

The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

a

the body so requests;

b

he considers that it is no longer a body in respect of which the applicable criteria for designation set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F386both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met; or

c

he considers that the body is not capable of fulfilling the functions of an importing Party arising out of F190a mutual recognition agreement which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

6

Before—

a

effecting a variation under paragraph (4); or

b

restricting or withdrawing a designation under paragraph (5),

otherwise than at F218the approved body’s request, the Secretary of State shall give to the F60approved body an opportunity to make representations to him in writing and shall take into account any such representations as are made.

7

For the purpose of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F429both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met as respects the tasks which the body wants to carry out, or carries out, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of F33a mutual recognition agreement which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

a

any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

b

any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

8

The Secretary of State may request that F186an approved body supply to him any or all relevant information and documents, including budgetary documents, necessary—

a

to enable him to verify that the body meets the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F214both read with Regulation (EU) No 722/2012, or Annex IX of Directive 98/79; or

b

for the purposes of deciding whether or not the body is capable of fulfilling the functions of an importing Party arising out of F485a mutual recognition agreement which it needs to be able to fulfil,

and the body shall supply to him any and all relevant information or documents so requested.

Designation etc. of UK notified bodiesE845

1

The Secretary of State may designate for the purposes of article 11 of Directive 90/385, article 16 of Directive 93/42 or article 15 of Directive 98/79 any corporate or other body as a body which is to carry out any of the tasks of a notified body F63with respect to devices to be placed on the market in Northern Ireland, and, if he so designates a body (referred to in these Regulations as a “UK notified body”), he shall designate the tasks which it is to carry out.

2

A body may be designated under paragraph (1) as a body which is to carry out tasks of a notified body only if—

a

in so far as it is to be designated as a body which is to carry out tasks included in Directive 90/385, it is a body in respect of which the criteria for the designation of notified bodies set out in Annex 8 of that Directive F626, read with Regulation (EU) No 722/2012, are met;

b

in so far as it is to be designated as a body which is to carry out tasks included in Directive 93/42, it is a body in respect of which the criteria for the designation of notified bodies set out in Annex XI of that Directive F575, read with F679Regulation (EU) No 722/2012, are met;

c

in so far as it is to be designated as a body which is to carry out tasks included in Directive 98/79, it is a body in respect of which the criteria for the designation of notified bodies set out in Annex IX of that Directive are met; and

d

in so far as it needs to be able to fulfil the functions of an importing Party arising out of the Mutual Recognition Agreements, it is able to do so.

3

The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

4

The Secretary of State may vary the tasks that a UK notified body may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

5

The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

a

the body so requests;

b

he considers that it is no longer a body in respect of which the applicable criteria for designation set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F642both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met; or

c

he considers that the body is not capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

6

Before—

a

effecting a variation under paragraph (4); or

b

restricting or withdrawing a designation under paragraph (5),

otherwise than at the notified body’s request, the Secretary of State shall give to the notified body an opportunity to make representations to him in writing and shall take into account any such representations as are made.

7

For the purpose of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F591both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met as respects the tasks which the body wants to carry out, or carries out, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

a

any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

b

any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

8

The Secretary of State may request that a UK notified body supply to him any or all relevant information and documents, including budgetary documents, necessary—

a

to enable him to verify that the body meets the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F630both read with Regulation (EU) No 722/2012, or Annex IX of Directive 98/79; or

b

for the purposes of deciding whether or not the body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil,

and the body shall supply to him any and all relevant information or documents so requested.

F394Choice of approved bodies and conformity assessment bodiesE1046

Where a conformity assessment procedure involves the intervention of F168an approved body, including work which may be carried out by a third country conformity assessment body, the manufacturer of a device or F95the manufacturer’s UK responsible person may apply to F233any approved body or third country conformity assessment body to carry out tasks under that procedure which are within the framework of tasks which the body is designated to carry out.

Choice of notified bodies and conformity assessment bodiesE7346

Where a conformity assessment procedure involves the intervention of a notified body, including work which may be carried out by a third country conformity assessment body, the manufacturer of a device or his authorised representative may apply to any notified body or third country conformity assessment body to carry out tasks under that procedure which are within the framework of tasks which the body is designated to carry out.

Annotations:
Extent Information
E73

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

F200General matters relating to approved bodiesE5547

1

F552An approved body to which an application has been made by a manufacturer or F548the manufacturer’s UK responsible person to perform the functions of F24an approved body under a conformity assessment procedure set out in F5these Regulations shall perform those functions, in accordance with the requirements of the procedure, if those functions are within the framework of tasks which the body is designated to carry out.

2

Where a manufacturer or F105the manufacturer’s UK responsible person has supplied information or data to F90an approved body in the course of a conformity assessment procedure, that body may, where duly justified, require the manufacturer to provide any additional information or data which it considers necessary for the purposes of that procedure.

3

The information, data and correspondence that a manufacturer or F154the manufacturer’s UK responsible person supplies to an approved body in the course of a conformity assessment procedure set out in F284these Regulations shall, F344..., be in English F81....

4

F9An approved body shall, as respects a medical device which it has assessed F428..., inform all F391other approved bodies and the Secretary of State of—

a

all certificates suspended or withdrawn; and

b

on request, all certificates issued or refused,

and shall also make available to them, on request, any or all additional relevant information.

5

Where F305an approved body finds, as respects a medical device which it has assessed F428..., that—

a

the applicable requirements of F338these Regulations have not been met or are no longer met; or

b

a certificate issued by it should not have been issued,

it may (having regard in particular to the principle of proportionality and the ability of the manufacturer to take appropriate corrective measures) suspend or withdraw the certificate issued in respect of that device or place restrictions on it, and in such cases, or in cases where the F388approved body is aware of circumstances in which the Secretary of State may need to take action pursuant to regulation 61, the F388approved body shall inform the Secretary of State thereof.

6

The Secretary of State may request that F188an approved body supply to him any information and documents that the Secretary of State may, having regard to the terms of F462a mutual recognition agreement, need to supply to a Party to F462a mutual recognition agreement, and the body shall supply to him any and all information or documents so requested.

8

F237An approved body shall provide conformity assessment bodies with all the information it is required to provide to those bodies under F466a mutual recognition agreement.

F3529

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F35210

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

General matters relating to UK notified bodiesE4147

1

A UK notified body to which an application has been made by a manufacturer or his authorised representative to perform the functions of a notified body under a conformity assessment procedure set out in the Medical Devices Directives shall perform those functions, in accordance with the requirements of the procedure, if those functions are within the framework of tasks which the body is designated to carry out.

2

Where a manufacturer or his authorised representative has supplied information or data to a UK notified body in the course of a conformity assessment procedure, that body may, where duly justified, require the manufacturer to provide any additional information or data which it considers necessary for the purposes of that procedure.

3

The information, data and correspondence that a manufacturer or his authorised representative supplies to a notified body in the course of a conformity assessment procedure set out in the Medical Devices Directives shall, if the notified body is within the United Kingdom, be in English or some other Community language acceptable to the notified body concerned.

4

A UK notified body shall, as respects a medical device which it has assessed F577..., inform all other notified bodies and the Secretary of State of—

a

all certificates suspended or withdrawn; and

b

on request, all certificates issued or refused,

and shall also make available to them, on request, any or all additional relevant information.

5

Where a UK notified body finds, as respects a medical device which it has assessed F577..., that—

a

the applicable requirements of the Medical Devices Directives have not been met or are no longer met; or

b

a certificate issued by it should not have been issued,

it may (having regard in particular to the principle of proportionality and the ability of the manufacturer to take appropriate corrective measures) suspend or withdraw the certificate issued in respect of that device or place restrictions on it, and in such cases, or in cases where the notified body is aware of circumstances in which the Secretary of State may need to take action pursuant to regulation 61, the notified body shall inform the Secretary of State thereof.

6

The Secretary of State may request that a UK notified body supply to him any information and documents that the Secretary of State may, having regard to the terms of the Mutual Recognition Agreements, need to supply to a Party to the Mutual Recognition Agreements, and the body shall supply to him any and all information or documents so requested.

8

A UK notified body shall provide conformity assessment bodies with all the information it is required to provide to those bodies under the Mutual Recognition Agreements.

F6279

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F62710

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F117Register of approved bodiesE2947A

1

The Secretary of State must ensure that—

a

each approved body is assigned an identification number; and

b

there is a register of—

i

approved bodies;

ii

their approved body identification number;

iii

the tasks for which they have been designated; and

iv

any restrictions on those tasks.

2

The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

3

The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).

F298Register of UK notified bodiesE1447A

1

The Secretary of State must ensure that—

a

each notified body established in the United Kingdom is assigned an identification number; and

b

there is a register of—

i

notified bodies established in the United Kingdom;

ii

their notified body identification number;

iii

the tasks for which they have been notified;

iv

any restrictions on those tasks.

2

The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

3

The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).

Designation etc. of F378... conformity assessment bodiesE8048

1

The Secretary of State may designate for the purposes of F251a mutual recognition agreement any corporate or other body as a body which is to carry out any of the tasks of a F150... conformity assessment body, and, if he so designates a body (referred to in these Regulations as F451a “CAB”), he shall designate the tasks which it is to carry out.

2

A body may be designated under paragraph (1) as a body which is to carry out tasks of F48a CAB only if the Secretary of State considers that the body is capable of fulfilling the functions of F48a CAB arising out of F178a mutual recognition agreement which it needs to be able to fulfil.

3

The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

4

The Secretary of State may vary the tasks that F416a CAB may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

5

The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

a

the body so requests; or

b

he considers that the body is not capable of fulfilling the functions of F205a CAB arising out of F398a mutual recognition agreement which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

6

Before—

a

effecting a variation under paragraph (4); or

b

restricting or withdrawing a designation under paragraph (5),

otherwise than at the F535... CAB’s request, the Secretary of State shall give to the F535... CAB an opportunity to make representations to him in writing and shall take into account any such representations as are made.

7

For the purpose of deciding whether or not a body is capable of fulfilling the functions of F337a CAB arising out of F181a mutual recognition agreement which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

a

any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

b

any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

8

The Secretary of State may request that F64a CAB supply to him any or all relevant information and documents, including budgetary documents, necessary for the purposes of deciding whether or not the body is capable of fulfilling the functions of F64a CAB arising out of F348a mutual recognition agreement which it needs to be able to fulfil, and the body shall supply to him any and all relevant information or documents so requested.

Designation etc. of F527... conformity assessment bodiesE6248

1

The Secretary of State may designate for the purposes of F225a UK mutual recognition agreement any corporate or other body as a body which is to carry out any of the tasks of a F102... conformity assessment body, and, if he so designates a body (referred to in these Regulations as F244a “CAB”), he shall designate the tasks which it is to carry out.

2

A body may be designated under paragraph (1) as a body which is to carry out tasks of F302a CAB only if the Secretary of State considers that the body is capable of fulfilling the functions of F302a CAB arising out of F488a UK mutual recognition agreement which it needs to be able to fulfil.

3

The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

4

The Secretary of State may vary the tasks that F259a CAB may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

5

The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

a

the body so requests; or

b

he considers that the body is not capable of fulfilling the functions of F2a CAB arising out of F371a UK mutual recognition agreement which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

6

Before—

a

effecting a variation under paragraph (4); or

b

restricting or withdrawing a designation under paragraph (5),

otherwise than at the F113... CAB’s request, the Secretary of State shall give to the F113... CAB an opportunity to make representations to him in writing and shall take into account any such representations as are made.

7

For the purpose of deciding whether or not a body is capable of fulfilling the functions of F465a CAB arising out of F420a UK mutual recognition agreement which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

a

any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

b

any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

8

The Secretary of State may request that F473a CAB supply to him any or all relevant information and documents, including budgetary documents, necessary for the purposes of deciding whether or not the body is capable of fulfilling the functions of F473a CAB arising out of F534a UK mutual recognition agreement which it needs to be able to fulfil, and the body shall supply to him any and all relevant information or documents so requested.

F286Fees charged by approved bodies and conformity assessment bodiesE2149

1

F475An approved body or CAB may charge a fee in accordance with paragraphs (2), (3) and (4) for anything done in, or in connection with—

F173a

in the case of an approved body, performing the functions of an approved body or an importing Party under these Regulations or a mutual recognition agreement; and

b

in the case of F359a CAB, performing the functions of F359a CAB arising out of F374a mutual recognition agreement in respect of a conformity assessment procedure for a medical device.

2

Except as provided for by paragraph (3), the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it.

3

Where the F427approved body or CAB charging the fee is a body the activities of which are carried on for profit, the fee may include an amount representing a profit which is reasonable in the circumstances, having regard to—

a

the character and extent of the work done or to be done by the F42approved body; and

b

the commercial rate normally charged in respect of profit for that work or similar work.

4

The F30approved body or CAB may require payment of the fee, or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work.

F264Fees charged by UK notified bodies and conformity assessment bodiesE6549

1

A UK notified body or F370CAB may charge a fee in accordance with paragraphs (2), (3) and (4) for anything done in, or in connection with—

a

in the case of a UK notified body, performing the functions of a notified body or an importing Party under F262the Medical Devices Directives or a UK mutual recognition agreement in respect of a conformity assessment procedure set out in the Medical Devices Directives or these Regulations as they apply in Great Britain; and

b

in the case of F158a CAB, performing the functions of F158a CAB arising out of F94a UK mutual recognition agreement in respect of a conformity assessment procedure for a medical device.

2

Except as provided for by paragraph (3), the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it.

3

Where the UK notified body or F493CAB charging the fee is a body the activities of which are carried on for profit, the fee may include an amount representing a profit which is reasonable in the circumstances, having regard to—

a

the character and extent of the work done or to be done by the notified body; and

b

the commercial rate normally charged in respect of profit for that work or similar work.

4

The UK notified body or F46CAB may require payment of the fee, or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work.

Products incorrectly marked with F438an approved body or conformity assessment body numberE7150

1

No person shall—

a

affix F290an approved body or conformity assessment body number to a medical device if that body has not carried out an assessment in respect of that device for that person;

b

supply a medical device (if that supply is also a placing on the market, or if that supply is of a device which has been placed on the market) which has affixed to it F290an approved body or conformity assessment body number if that body—

i

has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or

ii

has had its designation as F290an approved body or conformity assessment body withdrawn.

2

No person shall provide information comprising F400an approved body or conformity assessment body number on a medical device, the instructions for use for a medical device, or the sales packaging for a medical device if that device—

a

is being or has been placed on the market; and

b

F292the approved body or conformity assessment body—

i

has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or

ii

has had its designation as F400an approved body or conformity assessment body withdrawn.

3

Where the sectoral annex on medical devices in a Mutual Recognition Agreement under which a conformity assessment body was designated states that the annex does not apply to devices of a particular class or description, no person may supply a medical device of that class or description bearing the number of that conformity assessment body (if that supply is also a placing on the market or putting into service or is of a device that has been placed on the market or put into service) unless—

a

an assessment has been carried out on that device for the person responsible for placing it on the market or putting it into service by F29an approved body; and

b

the device bears the F347approved body number of that F347approved body.

4

For the purposes of this regulation, F112an approved body shall be taken to have carried out an assessment in respect of a device if it has endorsed a report prepared by a third country conformity assessment body in respect of that device.

Products incorrectly marked with a notified body or conformity assessment body numberE550

1

No person shall—

a

affix a notified body or conformity assessment body number to a medical device if that body has not carried out an assessment in respect of that device for that person;

b

supply a medical device (if that supply is also a placing on the market, or if that supply is of a device which has been placed on the market) which has affixed to it a notified body or conformity assessment body number if that body—

i

has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or

ii

has had its designation as a notified body or conformity assessment body withdrawn.

2

No person shall provide information comprising a notified body or conformity assessment body number on a medical device, the instructions for use for a medical device, or the sales packaging for a medical device if that device—

a

is being or has been placed on the market; and

b

the notified body or conformity assessment body—

i

has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or

ii

has had its designation as a notified body or conformity assessment body withdrawn.

3

Where the sectoral annex on medical devices in a Mutual Recognition Agreement under which a conformity assessment body was designated states that the annex does not apply to devices of a particular class or description, no person may supply a medical device of that class or description bearing the number of that conformity assessment body (if that supply is also a placing on the market or putting into service or is of a device that has been placed on the market or put into service) unless—

a

an assessment has been carried out on that device for the person responsible for placing it on the market or putting it into service by a notified body; and

b

the device bears the notified body number of that notified body.

4

For the purposes of this regulation, a notified body shall be taken to have carried out an assessment in respect of a device if it has endorsed a report prepared by a third country conformity assessment body in respect of that device.

Annotations:
Extent Information
E5

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Products incorrectly marked with a F78UK markingE8451

1

No person shall—

a

affix the F520UK marking for a medical device to a product which is not a medical device; or

b

supply a product (if that supply is also a placing on the market, or if that supply is of a product which has been placed on the market) which has affixed to it the F520UK marking for a medical device if that product is not a medical device.

2

No person shall provide information comprising a F520UK marking for a medical device on a product, the instructions for use for a product, or the sales packaging for a product if the product is not a medical device.

Products incorrectly marked with a CE markingE2651

1

No person shall—

a

affix the CE marking for a medical device to a product which is not a medical device; or

b

supply a product (if that supply is also a placing on the market, or if that supply is of a product which has been placed on the market) which has affixed to it the CE marking for a medical device if that product is not a medical device.

2

No person shall provide information comprising a CE marking for a medical device on a product, the instructions for use for a product, or the sales packaging for a product if the product is not a medical device.

Annotations:
Extent Information
E26

This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

PART VIFees charged by the Secretary of State

Interpretation of Part VI52

1

In this PartF191...—

  • F288“approved manufacturer” in relation to a medicinal substance means a manufacturer who—

    1. a

      holds a manufacturing authorisation which permits the manufacturer to manufacture that substance for inclusion in an authorised medicinal product; or

    2. b

      holds an examination certificate for a device incorporating that medicinal substance and that certificate was issued by an approved body or notified body after consultation with the Secretary of State in respect of that substance;

  • F288“authorised medicinal product” means a medicinal product in respect of which a marketing authorisation has been granted;

  • F288“clinical development” means the conduct of studies of a medicinal substance in human subjects in order to—

    1. a

      discover or verify the effects of such a substance,

    2. b

      identify any adverse reaction to such a substance, or

    3. c

      study absorption, distribution, metabolism and excretion of such a substance,

    with the object of ascertaining the safety or efficacy of that substance, as required to verify the safety and usefulness of the substance in accordance with section 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385;

  • F288“consultation” means a consultation required by—

    1. a

      section 4.3 of Annex II of Directive 93/42 or Directive 90/385; or

    2. b

      section 5 of Annex III of Directive 93/42 or Directive 90/385;

  • F288“examination certificate” means—

    1. a

      a design-examination certificate within the meaning of sections 4.3 and 4.4 of Annex II of Directive 93/42 or Directive 90/385, issued by an approved body;

    2. b

      a type-examination certificate within the meaning of sections 5 and 6 of Annex III of Directive 93/42 or Directive 90/385, issued by an approved body;

    3. c

      an EC design-examination certificate within the meaning of sections 4.3 and 4.4 of the version of Annex II of Directive 93/42 or Directive 90/385 that existed immediately before IP completion day, issued by a notified body; or

    4. d

      an EC type-examination certificate within the meaning of sections 5 and 6 of the version of Annex III of Directive 93/42 or Directive 90/385 that existed immediately before IP completion day), issued by a notified body;

  • F288“further consultation” means a consultation by an approved body in relation to any device which—

    1. a

      may be placed on the market or put into service in accordance with Part 2 or 3 and which is the subject of an examination certificate issued by that approved body after consultation with the Secretary of State;

    2. b

      is the subject of proposed changes within section 4.4 of Annex II of Directive 93/42 or Directive 90/385 or section 6 of Annex III of Directive 93/42 or Directive 90/385 and if that device is to be placed on the market or put into service, those changes may require a supplement to the examination certificate previously issued by that approved body after consultation with the Secretary of State; or

    3. c

      is of a similar design or type to a device which has been the subject of an unsuccessful application for an examination certificate where—

      1. i

        the person who made that unsuccessful application makes a further application for an examination certificate to the approved body which determined that unsuccessful application; and

      2. ii

        within the relevant period that further application becomes the subject of consultation between that approved body and the Secretary of State;

  • “Group A device” means a Class I medical device, a Class IIa medical device, or a Class IIb medical device which is neither an implantable device nor a long term invasive medical device;

  • “Group B device” means a Class IIb medical device which is either an implantable medical device or a long term invasive medical device, or a Class III medical device, or an active implantable medical device; and “half day” means a period of three and a half hours.

  • F288“incorporates” means incorporates as an integral part;

  • F288“marketing authorisation” has the meaning given by regulation 8 of the Human Medicines Regulations 2012;

  • F288“medicinal substance” means a substance which, if used separately from a device, may be considered to be a medicinal product, as defined in Schedule 1 to the Medicines (Products for Human Use) Fees Regulations 2016;

  • F288“new medicinal substance” means a medicinal substance which is not—

    1. a

      an authorised medicinal product;

    2. b

      an ingredient or, as the case may be, the sole active ingredient of such a product; or

    3. c

      a substance which has been incorporated in a device in respect of which an examination certificate has been issued by an approved body which has consulted the Secretary of State;

  • F288“quality development” means the chemical, pharmaceutical and biological testing required in order to verify the quality of a medicinal substance in accordance with paragraph 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385;

  • F288“relevant period” means the period of 5 years which starts on the first day on which the Secretary of State was consulted in respect of the unsuccessful application or, if there has been more than one such application in any particular case, in respect of the first of them;

  • F288“safety development” means the toxicological and pharmacological testing required in order to verify the safety of a medicinal substance in accordance with paragraph 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385; and

  • F288“scientific advice” means advice in connection with the quality, safety or clinical development for a medicinal substance incorporated, or to be incorporated, in a device.

2

For the purposes of this Part, medical devices are classified as being implantable or long term invasive medical devices in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42, and in the event of a dispute over the classification of a device, the Secretary of State shall determine the classification of the device in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42.

Fees in connection with the registration of devices and changes to registration detailsE453

Any person required to supply the Secretary of State with any information under F247regulation 7A, 19, 21A, 33A or 44 shall, in respect of the processing of that information with regard to the possible registration of that person by the Secretary of State or possible changes to his registration details, pay to the Secretary of State a fee of F171£240, and that fee—

a

shall be payable when the information is supplied by that person to the Secretary of State; and

b

shall accompany that information when it is supplied.

Fees in connection with the registration of devices and changes to registration detailsE1653

Any person required to supply the Secretary of State with any information under regulation 19 F291, 21B or 44 shall, in respect of the processing of that information with regard to the possible registration of that person by the Secretary of State or possible changes to his registration details, pay to the Secretary of State a fee of F328£240, and that fee—

a

shall be payable when the information is supplied by that person to the Secretary of State; and

b

shall accompany that information when it is supplied.

F198Fees payable in connection with the designation of approved bodiesE9054

1

A corporate or other body that applies to the Secretary of State for designation under regulation 45 as F187an approved body shall, in connection with that application for designation, pay to the Secretary of State—

a

if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of F163£8,918; or

b

in all other cases, a fee of F503£35,672.

F5512

A corporate or other body that applies to the Secretary of State for a variation under regulation 45(4) must, in connection with that application for a variation, pay to the Secretary of State—

a

in respect of an extension to the scope of the body’s designation to carry out tasks under Part 2, Part 3 or Part 4, which extends the body’s designation in relation to a Part under which they have already been designated, a fee of £12,571;

b

in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and where the Secretary of State considers that an additional assessment of the body’s procedures is required, a fee of £18,212.

3

Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F41both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of F387a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—

F446a

in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of F463£58,341 plus the amounts specified in paragraph (3A);

F349b

in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection, a fee of £45,675, plus the amounts specified in paragraph (3A); and

c

in respect of an inspection pursuant to regulation 45(7)(b), a fee of F470£10,072 plus the amounts specified in paragraph (3A).

F73A

Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be—

a

an amount for time spent by a member of staff undertaking a site visit at a rate—

i

for the time spent on site, of F129£631 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

ii

for the time spent travelling to and from the site, of F21£171 per hour;

b

the actual costs of travel, accommodation and subsistence; and

c

out of pocket expenses.

3B

Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)—

a

the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and

b

the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).

F4583C

F202An approved body that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—

a

a fee of F254£35,672 in respect of the application; and

b

where an audit is carried out in connection with the application, a fee of F318£58,341 in respect of the audit F13,

plus the amounts specified in paragraph (3A).

3D

Where the Secretary of State conducts an assessment of F256an approved body pursuant to article 5 of Regulation (EU) No 920/2013, F528the approved body shall pay to the Secretary of State—

a

if the assessment relates to the UK notified body’s assessment of clinical data only, a fee of F57£18,583; or

b

in any other case, a fee of F215£22,789F521,

plus the amounts specified in paragraph (3A).

3E

F342An approved body that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of F61£1,297.

F2173F

Where, pursuant to regulation 45(7)(a) or 45(7)(b), the Secretary of State conducts an on-site assessment of a subsidiary of the body, the body must pay to the Secretary of State a fee of £22,789, plus the costs and expenses referred to in paragraph (3A).

4

A fee under this regulation—

a

in connection with an application for designation under F226regulation 45(1), a variation under regulation 45(4)F216, a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012—

i

shall be payable when the application F14or submission to the Secretary of State is made, and

ii

shall accompany the application F522or submission when it is made;

b

in connection with an inspection pursuant to regulation 45(7) F152or an audit or assessment pursuant to Regulation (EU) No 920/2013, shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

F4125

In this regulation—

  • “Regulation (EU) No 920/2013” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices; and

  • “subsidiary” is to be construed in accordance with section 1159 of the Companies Act 2006.

Fees payable in connection with the designation etc. of UK notified bodiesE1754

1

A corporate or other body that applies to the Secretary of State for designation under regulation 45 as a notified body shall, in connection with that application for designation, pay to the Secretary of State—

a

if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of F620£2,063; or

b

in all other cases, a fee of F640£8,252.

2

A corporate or other body that applies to the Secretary of State for a variation under regulation 45(4) of the tasks that the body may carry out shall, in connection with that application for a variation, pay to the Secretary of State a fee of F597£6,504.

3

Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F600both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, the body shall pay to the Secretary of State—

F621a

in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of F653£15,904 plus the amounts specified in paragraph (3A);

b

in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection—

i

if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in all three of the Annexes referred to in this paragraph are met, a fee of F658£10,160,

ii

if the inspection is for the purpose of deciding whether or not the body is one in respect of which the criteria set out in only two of the three Annexes referred to in this paragraph are met, a fee of F658£10,160, or

iii

if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in only one of the Annexes referred to in this paragraph are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, a fee of F658£10,160,

plus the amounts specified in paragraph (3A); and

c

in respect of an inspection pursuant to regulation 45(7)(b), a fee of F612£4,404 plus the amounts specified in paragraph (3A).

F6053A

Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be—

a

an amount for time spent by a member of staff undertaking a site visit at a rate—

i

for the time spent on site, of F635£361.20 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

ii

for the time spent travelling to and from the site, of F649£90.30 per hour;

b

the actual costs of travel, accommodation and subsistence; and

c

out of pocket expenses.

3B

Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)—

a

the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and

b

the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).

F5993C

A UK notified body that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—

a

a fee of £8,252 in respect of the application; and

b

where an audit is carried out in connection with the application, a fee of £15,904 in respect of the audit.

3D

Where the Secretary of State conducts an assessment of a UK notified body pursuant to article 5 of Regulation (EU) No 920/2013, the UK notified body shall pay to the Secretary of State—

a

if the assessment relates to the UK notified body’s assessment of clinical data only, a fee of £2,586; or

b

in any other case, a fee of £3,876.

3E

A UK notified body that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of £532.

4

A fee under this regulation—

a

in connection with an application for designation under F646regulation 45(1), a variation under regulation 45(4)F668, a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012—

i

shall be payable when the application F623or submission to the Secretary of State is made, and

ii

shall accompany the application F681or submission when it is made;

b

in connection with an inspection pursuant to regulation 45(7) F665or an audit or assessment pursuant to Regulation (EU) No 920/2013, shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

F6135

In this regulation, “Regulation (EU) No 920/2013” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.

F71 Fees payable in connection with the designation etc. of ... conformity assessment bodiesE4255

1

A corporate or other body that applies to the Secretary of State for designation under regulation 48 as F270a CAB shall, in connection with that application for designation, pay to the Secretary of State—

a

if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of F455£8,918; or

b

in all other cases, a fee of F480£35,672.

F1932

A corporate or other body that applies to the Secretary of State for a variation under regulation 48(4) must, in connection with that application for a variation, pay to the Secretary of State—

a

in respect of an extension to the scope of the body’s designation to carry out tasks arising out of a mutual recognition agreement that were not previously within the scope of the body’s designation, a fee of £12,571; or

b

in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and which requires the Secretary of State to undertake an additional assessment of the body’s procedures, a fee of £18,212.

3

F206Subject to paragraphs (3A) to (3C) where, pursuant to regulation 48(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is capable of fulfilling the functions of F547a CAB arising out of F119a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—

F529a

in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of F238£58,341 plus the amounts specified in paragraph (3D);

b

in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of F27£10,072 plus the amounts specified in paragraph (3D);

c

in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of F170£1,880;

d

in respect of an inspection pursuant to regulation 48(7)(b), a fee of F145£10,072 plus the amounts specified in paragraph (3D).

F4073A

Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be F162£58,341 plus—

a

F87£1,880 for each additional inspection; and

b

the amounts specified in paragraph (3D).

3B

Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be F287£10,072 plus—

a

F45£1,880 for each additional inspection; and

b

the amounts specified in paragraph (3D)

3C

Where the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be F440£1,880 for each inspection.

3D

The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be—

a

an amount for time spent by a member of staff undertaking a site visit at a rate—

i

for the time spent on site, of F508£631 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

ii

for the time spent travelling to and from the site, of F37£171 per hour;

b

the actual costs of travel, accommodation and subsistence, and

c

out of pocket expenses.

4

A fee under this regulation—

a

in connection with an application for designation under regulation 48(1) or a variation under regulation 48(4)—

i

shall be payable when the application to the Secretary of State is made, and

ii

shall accompany the application when it is made;

b

in connection with an inspection pursuant to regulation 48(7), shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

F243 Fees payable in connection with the designation etc. of ... conformity assessment bodiesE8355

1

A corporate or other body that applies to the Secretary of State for designation under regulation 48 as F77a CAB shall, in connection with that application for designation, pay to the Secretary of State—

a

if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of F376£8,918; or

b

in all other cases, a fee of F219£35,672.

F3732

A corporate or other body that applies to the Secretary of State for a variation under regulation 48(4) must, in connection with that application for a variation, pay to the Secretary of State—

a

in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out tasks arising out of a UK mutual recognition agreement that were not previously within the scope of the body’s designation, a fee of £12,571; or

b

in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and which requires the Secretary of State to undertake an additional assessment of the body’s procedures, a fee of £18,212.

3

F636Subject to paragraphs (3A) to (3C) where, pursuant to regulation 48(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is capable of fulfilling the functions of F49a CAB arising out of F240a UK mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—

F648a

in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of F550£58,341 plus the amounts specified in paragraph (3D);

b

in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of F220£10,072 plus the amounts specified in paragraph (3D);

c

in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of F604£1,880;

d

in respect of an inspection pursuant to regulation 48(7)(b), a fee of F53£10,072 plus the amounts specified in paragraph (3D).

F6173A

Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be F496£58,341 plus—

a

F608£1,880 for each additional inspection; and

b

the amounts specified in paragraph (3D).

3B

Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be F333£10,072 plus—

a

F682£1,880 for each additional inspection; and

b

the amounts specified in paragraph (3D)

3C

Where the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be F586£1,880 for each inspection.

3D

The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be—

a

an amount for time spent by a member of staff undertaking a site visit at a rate—

i

for the time spent on site, of F194£631 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

ii

for the time spent travelling to and from the site, of F435£171 per hour;

b

the actual costs of travel, accommodation and subsistence, and

c

out of pocket expenses.

4

A fee under this regulation—

a

in connection with an application for designation under regulation 48(1) or a variation under regulation 48(4)—

i

shall be payable when the application to the Secretary of State is made, and

ii

shall accompany the application when it is made;

b

in connection with an inspection pursuant to regulation 48(7), shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

Fees payable in relation to clinical investigation noticesE7056

1

Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—

a

if, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—

i

a fee, if the device is a Group A device, of F468£5,711, or

ii

a fee, if the device is a Group B device, of F212£11,069; or

b

in all other cases—

i

a fee, if the device is a Group A device, of F68£7,472, or

ii

a fee, if the device is a Group B device, of F324£15,627.

2

Except where paragraph (3) F137or (3A) applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or F245their UK responsible person has previously given such notice in relation to that device.

3

A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—

a

a change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;

b

a change to the number of patients or devices forming the basis of the proposed trial;

c

a change or extension in the indications for use of the device or to the purpose or objectives of the trial;

d

a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; or

e

a change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.

F1663A

Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—

a

a fee, if the device is a Group A device, of £207; or

b

a fee, if the device is a Group B device, of £331.

F1403B

A person who requests a meeting with the Secretary of State in respect of an intended clinical investigation under regulation 16(1A) or 29(1A) must pay the following fees in advance of the meeting—

a

£906 for a regulatory advice meeting under regulation 16(1A)(a) or 29(1A)(a); and

b

£782 for a statistical review meeting under regulation 16(1A)(b) or 29(1A)(b).

4

A fee under this regulation—

a

shall be payable when the notice to which it relates is given to the Secretary of State; and

b

shall accompany that notice when it is given.

Fees payable in relation to clinical investigation noticesE1556

1

Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—

a

if, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—

i

a fee, if the device is a Group A device, of F643£2,920, or

ii

a fee, if the device is a Group B device, of F643£3,570; or

b

in all other cases—

i

a fee, if the device is a Group A device, of F584£3,820, or

ii

a fee, if the device is a Group B device, of F584£5,040.

2

Except where paragraph (3) F651or (3A) applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or his authorised representative has previously given such notice in relation to that device.

3

A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—

a

a change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;

b

a change to the number of patients or devices forming the basis of the proposed trial;

c

a change or extension in the indications for use of the device or to the purpose or objectives of the trial;

d

a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; or

e

a change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.

F6553A

Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—

a

a fee, if the device is a Group A device, of £207; or

b

a fee, if the device is a Group B device, of £331.

4

A fee under this regulation—

a

shall be payable when the notice to which it relates is given to the Secretary of State; and

b

shall accompany that notice when it is given.

F453Fees in connection with approval of coronavirus test devices56A

1

A person who makes an application to the Secretary of State under regulation 38A(1) must pay to the Secretary of State a fee of—

a

£14,000; or

b

if the person is a small or medium-sized enterprise, £6,200.

2

Where the Secretary of State, in accordance with regulation 38A(4), treats an application made before the coming into force of regulation 38A as an application made under that regulation, a payment made in respect of that application before the coming into force of this regulation must be treated as—

a

a payment meeting the requirements of paragraph (1), if that payment would have met those requirements after their coming into force; or

b

a payment contributing in part to the payment required by paragraph (1), if that payment would not have met those requirements after their coming into force.

3

In this regulation—

a

a person is a small or medium-sized enterprise if it and persons associated with it employ no more than 250 individuals in total; and

b

“persons associated with it” has the same meaning as in section 882 of the Corporation Tax Act 2010.

F497Circumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device56B

1

Subject to paragraph (2), the fee payable by an approved body in respect of a consultation or further consultation with the Secretary of State in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device is the fee specified in regulation 56C.

2

No fee is payable if it is the first time the Secretary of State has been consulted by any approved body in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device if the medicinal substance is an authorised medicinal product.

F221Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device56C

1

Subject to regulation 56B(2) and paragraph (3), the fee in respect of a consultation in relation to a device which incorporates one or more medicinal substances is—

a

£4,550 if each medicinal substance is manufactured by an approved manufacturer of that substance;

b

£10,604 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

2

Subject to paragraph (3), the fee in respect of a further consultation in relation to a device which incorporates one or more medicinal substances is—

a

£900 if each medicinal substance is manufactured by an approved manufacturer of that substance;

b

£2,451 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

3

In relation to a device which incorporates a new medicinal substance, the fee is—

a

£46,526 for a consultation; and

b

£11,551 for a further consultation.

4

Where an approved body consults the Secretary of State in relation to more than one device at the same time and those devices—

a

are of similar construction and are designed to perform similar functions;

b

incorporate medicinal substances of the same specification which are manufactured by the same manufacturer or manufacturers; and

c

do not incorporate any other medicinal substance;

the fee payable for that consultation is the fee which would be payable under this regulation for a consultation in relation to one of those devices.

5

Any fee payable under this regulation must be paid to the Secretary of State not later than the day on which an approved body consults the Secretary of State.

F263Fees payable in connection with pre-consultation meetings56D

1

The fee payable by a person other than an approved body with whom the Secretary of State holds a meeting in order to provide scientific advice with a view to that person making an application for an examination certificate in relation to a device incorporating a medicinal substance is specified in paragraph (3).

2

The fee payable by an approved body with whom the Secretary of State holds a meeting in order to provide scientific advice with a view to that body consulting the Secretary of State in relation to an application for an examination certificate in relation to a device incorporating a medicinal substance is specified in paragraph (3).

3

The fee payable is—

a

£824, if the advice provided at that meeting consists of advice in connection with—

i

quality development only, or

ii

safety development only;

b

£1,044, if the advice provided at that meeting consists of advice in connection with—

i

quality and safety development only, or

ii

clinical development only;

c

£1,429, if the advice provided at that meeting consists of advice in connection with—

i

quality and clinical development only, or

ii

safety and clinical development only;

d

£1,813, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.

4

Any fee payable under this regulation must be paid within 14 days following written notice from the Secretary of State requiring payment of that fee

Unpaid fees57

All unpaid sums due by way of, or on account of, any fees payable under this Part are recoverable as debts due to the Crown.

Waivers, reductions and refunds58

1

The Secretary of State may—

a

waive payment of any fee or reduce any fee or part of a fee otherwise payable under this Part;

b

refund the whole or part of any fee paid pursuant to this Part.

2

Without prejudice to the generality of paragraph (1), where—

a

a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) is withdrawn within the period of 7 days beginning with the date of its receipt by the Secretary of State; or

b

an application for designation as—

i

F279an approved body under regulation 45(1), or

ii

F477a CAB under regulation 48(1),

(other than one submitted only to address the grounds of rejection of a previous application) is withdrawn within the period of 21 days beginning with the date of its receipt by the Secretary of State,

the fee payable shall be reduced to fifty per cent of the fee otherwise payable in respect of such notice or application, and any excess already paid shall be refunded.

Waivers, reductions and refunds58

1

The Secretary of State may—

a

waive payment of any fee or reduce any fee or part of a fee otherwise payable under this Part;

b

refund the whole or part of any fee paid pursuant to this Part.

2

Without prejudice to the generality of paragraph (1), where—

a

a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) is withdrawn within the period of 7 days beginning with the date of its receipt by the Secretary of State; or

b

an application for designation as—

i

a notified body under regulation 45(1), or

ii

F367a CAB under regulation 48(1),

(other than one submitted only to address the grounds of rejection of a previous application) is withdrawn within the period of 21 days beginning with the date of its receipt by the Secretary of State,

the fee payable shall be reduced to fifty per cent of the fee otherwise payable in respect of such notice or application, and any excess already paid shall be refunded.

PART VIIGeneral, Enforcement and Miscellaneous

Interpretation of Part VII59

In this Part F526...—

  • F50“registrable device” means a device in respect of which, in accordance with the Medical Devices Directives, registration is required with the competent authorities of a Member State or (where appropriate) a State which is a Party to an Association Agreement;

  • “relevant device” means a device that is a “relevant device” for the purposes of Part II, III or IV F459....

F66Status of UK responsible personE7860

F1741

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1742

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1513

A UK responsible person—

a

may be proceeded against as a person placing the device on the market for the purposes of these regulations;

b

in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market.

4

If a person claims or purports to act as F294a UK responsible person, the Secretary of State may, for the purposes of enabling the Secretary of State to exercise his functions under these Regulations, require that person to furnish the Secretary of State with sufficient F490evidence that he is F384a UK responsible person.

Designation etc. of authorised representativesE7960

1

Where these Regulations place any obligationF120... on a manufacturer of a device or his authorised representative, and the manufacturer does not have a registered place of business F261in a relevant state, no person shall—

a

place that device on the market; or

b

supply that device in circumstances where it has been placed on the market,

unless the manufacturer of the device has designated F580a single authorised representative to perform that obligation, but once the manufacturer has designated F580a single authorised representative to perform that obligation, that obligation shall be performed by the authorised representative (although in all other cases it shall be performed by the manufacturer).

2

If the manufacturer of a registrable device does not have a registered place of business F189in a relevant state, no person shall place that device on the market or supply that device in circumstances where it has been placed on the market unless its manufacturer has designated F580a single authorised representative as—

a

the person responsible for marketing the device F563in a relevant state; and

b

the person responsible for registering in respect of that device with—

i

the Secretary of State in accordance with regulation 19 or, as the case may be, 44, or

ii

the competent authorities of another Member State or (where appropriate) a State which is a Party to an Association Agreement.

3

Where a manufacturer of a registrable device, or of a relevant device that is not registrable, has designated F580a single authorised representative as the person responsible for marketing the device within F157a relevant state, that authorised representative—

a

may be proceeded against as a person placing the device on the market for the purposes of these Regulations;

b

in relation to any supply of the device to a person within F111Northern Ireland after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market, unless that supply is due to an act of another person established in F397a relevant state.

4

If a person claims or purports to act as an authorised representative of a manufacturer of a device, the Secretary of State may, for the purposes of enabling the Secretary of State to exercise his functions under these Regulations, require that person to furnish the Secretary of State with sufficient F632evidence that he is the single authorised representative of the manufacturer.

Enforcement etc.F10061

1A

It is the duty of the Secretary of State to enforce these regulations in relation to relevant devices and devices for performance evaluation.

1B

It is the duty of each weights and measures authority in Great Britain and each district council in Northern Ireland to enforce these regulations within its area (concurrently with the Secretary of State) in relation to relevant devices that are ordinarily intended for private use or consumption.

1C

Nothing in this regulation authorises a weights and measures authority to bring proceedings in Scotland for an offence.

Enforcement etc.E4661

1

Notwithstanding that they are made partly in exercise of powers other than those conferred by section 11 of the 1987 Act, these Regulations shall be regarded for all purposes relating to enforcement (whether by criminal proceedings, notices or otherwise) F590... as safety regulations as defined in that Act F614, and any provision of these Regulations made under those other powers shall be regarded for those purposes as a safety provision as defined in that Act M11.

F791A

Paragraph (1) applies in relation to regulations 10A, 24A and 36A (UK(NI) indication) as it does in relation to any other provision of these Regulations to which it applies.

2

Except as provided by paragraph (3), F73... each district council in Northern Ireland is relieved of its duty imposed by section 27(1) of the 1987 Act in so far as it is exercisable in relation to relevant devices or devices for performance evaluation, and that duty is transferred to the Secretary of State.

3

Paragraph (2) does not relieve an authority or council of its duty in relation to devices which are consumer goodsF593..., and accordingly but subject to paragraph (4), F308... each district council in Northern Ireland shall, concurrently with the Secretary of State, enforce these Regulations in relation to such devices.

4

The powers of an enforcement authority to serve restriction notices under regulation 63 are only exercisable by the Secretary of State.

5

Each F277... council referred to in paragraph (3) on whom a duty is imposed by section 27(1) of the 1987 Act to enforce the provisions of these Regulations shall give immediate notice to the Secretary of State of—

a

any suspension notice served by it under section 14 of the 1987 Act in respect of a device to which paragraph (3) applies;

b

any application made by it under section 16 of the 1987 Act for an order for forfeiture of any such device; and

c

any other thing done by it in respect of such a device for the purposes of, or in connection with the operation of, sections 14 to 17 of the 1987 Act.

F6226

In respect of an offence committed under section 12 of the 1987 Act relating to a contravention of these Regulations—

F175a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

b

a magistrates’ court in Northern Ireland may hear and determine any complaint made—

i

if the offence was committed before 10th March 2007, within 12 months from the time when the offence is committed, or

ii

if the offence was committed on or after 10th March 2007, within three years from the time when the offence was committed or within one year from the discovery of the offence by the prosecutor, whichever is the earlier; and

F372c

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

The powers conferred by section 13 of the 1987 Act to serve prohibition notices and notices to warn are exercisable in relation to non—conforming devices as they are exercisable in relation to relevant goods which the Secretary of State considers are unsafe (as well as being exercisable in relation to goods considered unsafe by the Secretary of State), and in relation to non-conforming devices, Schedule 2 to the 1987 Act shall have effect as if references to goods being unsafe or safe were references to relevant devices being or not being non-conforming devices.

F6707A

In paragraph (3), “consumer goods” means any goods which are ordinarily intended for private use or consumption.

8

In paragraph (7), “non-conforming devices” means—

a

relevant devices which, whether or not the Secretary of State considers them unsafe, are devices with or that require a CE marking which he considers to be devices—

i

which do not conform as respects a relevant essential requirement F573or a requirement of Regulation (EU) No 722/2012 (if applicable); or

ii

to which a CE marking has or should have been applied following a conformity assessment procedure set out in the Medical Devices Directives, and—

aa

the manufacturer or his authorised representative has failed to comply with his obligations under that procedure, or

bb

they do not conform to the design or type described in any certificate granted as a result of that procedure; or

b

devices for performance evaluation which, whether or not the Secretary of State considers them unsafe, are devices in respect of which there is a failure to comply with these Regulations.

Compliance noticesF162

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Restriction noticesF30763

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Notification of decisions etc.F48264

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15 Centralised systems of records etc.65

The Secretary of State shall perform, as respects F538Northern Ireland, the functions of the Member State under article 8 of Directive 90/385, article 10 of Directive 93/42 and article 11(1) to (3) of Directive 98/79.

Revocations66

The following provisions are hereby revoked—

a

the Active Implantable Medical Devices Regulations 1992 M3;

b

the Medical Devices Regulations 1994 M4;

c

the Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995 M5;

d

the Medical Devices Fees Regulations 1995 M6;

e

the Medical Devices Fees (Amendment) Regulations 1997 M7;

f

theIn Vitro Diagnostic Medical Devices Regulations 2000 M8; and

g

regulations 6 and 13 of the Medicines (Codification Amendments Etc.) Regulations 2002 M9.

F176ReviewE5667

Before the end of 31st December F1152025, the Secretary of State must—

a

carry out a review of these Regulations;

b

set out the conclusions of the review in a report; and

c

publish the report.

F685ReviewE4867

Before the end of 31st December 2019, the Secretary of State must—

a

carry out a review of these Regulations;

b

set out the conclusions of the review in a report; and

c

publish the report.

Signed by authority of the Secretary of State for Health

HuntParliamentary Under Secretary of State,Department of Health

We consent,

Tony McNulty Nick AingerTwo of the Lords Commissioners of Her Majesty’s Treasury