The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024

PART 4 Amendments to the Medical Devices (Northern Ireland Protocol) Regulations 2021

Amendment to the Medical Devices (Northern Ireland Protocol) Regulations 2021

27.  The Medical Devices (Northern Ireland Protocol) Regulations 2021(1) are amended in accordance with regulations 28 to 44.

Amendment to regulation 2 (extent and application)

28.  In regulation 2(2)—

(a) after “Parts 2,” insert “2A,”; and

(b) after “3” insert “, 3A”.

Amendment to regulation 3 (interpretation)

29.  In regulation 3—

(a) in paragraph (1)—

(i) after the definition of “Regulation (EU) 2017/745” insert—

““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;”

(ii) after the definition of “ethics committee” insert—

““Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators;

“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(2).”;

(b) for paragraph (2) substitute—

“(2) Unless otherwise defined in these Regulations—

(a) terms used in Parts 2 and 3 have the same meaning as in Regulation (EU) 2017/745;

(b) terms used in Parts 2A and 3A have the same meaning as in Regulation (EU) 2017/746.”;

(c) for paragraph (3) substitute—

“(3) In these Regulations, a reference to an Article or an Annex is—

(a) in Parts 2 and 3, a reference to an Article or an Annex of Regulation (EU) 2017/745;

(b) in Parts 2A and 3A, a reference to an Article or an Annex of Regulation (EU) 2017/746.”.

Amendment to regulation 4 (scope)

30.  For regulation 4 substitute—

“Scope

4.   In these Regulations—

(a) Parts 4, 5 and 6 apply to all devices to which Regulation (EU) 2017/745 and Regulation (EU) 2017/746 apply;

(b) Parts 2 and 3 apply to all devices to which Regulation (EU) 2017/745 applies;

(c) Parts 2A and 3A apply to all devices to which Regulation (EU) 2017/746 applies.”.

Amendment to regulation 8 (certificates of free sale – fee)

31.  In the heading of regulation 8, after “free sale” insert “under Regulation (EU) 2017/745”.

Amendment to regulation 10 (UK(NI) indication)

32.  In regulation 10—

(a) at the end of the heading insert “under Regulation (EU) 2017/745”;

(b) in paragraph (4)(b) omit “or putting the device into service”;

(c) in paragraph (5) omit “or put into service”;

(d) omit paragraph (6).

New Part 2A (Making available on the market and putting into service under Regulation (EU) 2017/746)

33.  After Part 2 insert—

“Part 2A Making available on the market and putting into service under Regulation (EU) 2017/746

Certificates of free sale under Regulation (EU) 2017/746 – fee

10A.   A manufacturer or authorised representative who requests a certificate of free sale from the Secretary of State under Article 55 must pay to the Secretary of State a fee of £75.

Retention of documentation relating to conformity assessments

10B.— (1) The liquidator or trustee in bankruptcy of a manufacturer, or of an authorised representative, must—

(a) retain for the required period any documentation that consists of, or reasonably could consist of, information to which section 7 of Annex IX applies, and

(b) comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.

(2) In this regulation, the required period is 10 years after the last device was placed on the market.

UK(NI) indication under Regulation (EU) 2017/746

10C.— (1) This regulation applies if the CE marking is affixed in accordance with Article 18 on the basis of a certificate issued by a notified body established in the United Kingdom.

(2) The CE marking must be accompanied by the UK(NI) indication.

(3) 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 manufacturer must affix the UK(NI) indication—

(a) visibly, legibly and indelibly, and

(b) before placing the device on the market.

(5) A person may only make available on the market a device to which this regulation applies if the manufacturer has affixed the UK(NI) indication in accordance with this regulation.”.

New regulation A11 (legal representatives and contact persons for clinical investigations)

34.  In Part 3 (clinical investigations under Regulation (EU) 2017/745), before regulation 11 insert—

“Legal representatives and contact persons for clinical investigations

A11.— (1) The first subparagraph of Article 62(2) (requirement to have a legal representative established in the Union) does not apply to a clinical investigation conducted in Northern Ireland if all of the following conditions are met—

(a) the clinical investigation is also being conducted in Great Britain;

(b) the clinical investigation is not also being conducted in a Member State;

(c) the sponsor—

(i) is established in Great Britain, or

(ii) has a written agreement with a legal representative established in Great Britain who is responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745;

(d) the sponsor has a contact person established in Northern Ireland in respect of the clinical investigation.

(2) A contact person referred to in this regulation must be the addressee for all communications with the sponsor provided for in Regulation (EU) 2017/745 and any communication with that contact person is deemed to be a communication with the sponsor.

(3) The agreement referred to in paragraph (1)(c)(ii) must provide for—

(a) the legal representative to be responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745,

(b) the legal representative to immediately inform the sponsor of all communications received in its capacity as the sponsor’s legal representative, and

(c) the sponsor to share with its legal representative all communications and documentation necessary to enable the legal representative to fulfil its obligations under this regulation.

(4) A legal representative referred to in paragraph (1)(c)(ii) must have a written agreement with the contact person to provide for—

(a) the contact person to immediately inform the legal representative of all communications received in its capacity as the sponsor’s contact person, and

(b) the legal representative to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

(5) Where the sponsor is established in Great Britain, the sponsor must have a written agreement with the contact person to provide for—

(a) the contact person to immediately inform the sponsor of all communications received in its capacity as the sponsor’s contact person, and

(b) the sponsor to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

(6) Where the sponsor has a legal representative established in Great Britain, the application form and the clinical investigation plan drawn up in accordance with chapter II of Annex XV must include the name, address and contact details of the legal representative established in Great Britain.”.

Amendment to regulation 13 (arbitration following the refusal of a clinical investigation application)

35.  In regulation 13 omit paragraph (6).

New Part 3A (Performance studies under Regulation (EU) 2017/746)

36.  After Part 3 insert—

“Part 3A Performance studies under Regulation (EU) 2017/746

Legal representatives and contact persons for performance studies

17B.— (1) The first subparagraph of Article 58(4) (requirement to have a legal representative established in the Union) does not apply to a performance study conducted in Northern Ireland if all of the following conditions are met—

(a) the performance study is also being conducted in Great Britain;

(b) the performance study is not also being conducted in a Member State;

(c) the sponsor—

(i) is established in Great Britain, or

(ii) has a written agreement with a legal representative established in Great Britain who is responsible for ensuring compliance with the sponsor’s obligations under Regulation (EU) 2017/746;

(d) the sponsor has a contact person established in Northern Ireland in respect of the performance study.

(2) A contact person referred to in this regulation must be the addressee for all communications with the sponsor provided for in Regulation (EU) 2017/746 and any communication with that contact person is deemed to be a communication with the sponsor.

(3) The agreement referred to in paragraph (1)(c)(ii) must provide for—

(a) the legal representative to be responsible for ensuring compliance with the sponsor’s obligations under Regulation (EU) 2017/746,

(b) the legal representative to immediately inform the sponsor of all communications received in its capacity as the sponsor’s legal representative, and

(c) the sponsor to share with its legal representative all communications and documentation necessary to enable the legal representative to fulfil its obligations under this regulation.

(4) A legal representative referred to in paragraph (1)(c)(ii) must have a written agreement with the contact person to provide for—

(a) the contact person to immediately inform the legal representative of all communications received in its capacity as the sponsor’s contact person, and

(b) the legal representative to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

(5) Where the sponsor is established in Great Britain, the sponsor must have a written agreement with the contact person to provide for—

(a) the contact person to immediately inform the sponsor of all communications received in its capacity as the sponsor’s contact person, and

(b) the sponsor to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

(6) Where the sponsor has a legal representative established in Great Britain, the application form drawn up in accordance with Chapter I of Annex XIV and any clinical performance study plan drawn up in accordance with Part A of Annex XIII must include the name, address and contact details of the legal representative established in Great Britain.

Ethical review of performance studies

17C.— (1) In Regulation (EU) 2017/746 a reference to an ethics committee is a reference to an ethics committee within the meaning of regulation 3(1).

(2) In relation to a performance study to which Article 58(5)(b) applies, the sponsor must submit to the Secretary of State a copy of the opinion of the ethics committee as soon as it becomes available and before the performance study starts.

Arbitration following the refusal of a performance study application

17D.— (1)  A sponsor notified of a refusal under Articles 66(3), 67(4) or 74(10) may, within 28 days of being notified, apply to the Institute to appoint an adjudicator to review the refusal.

(2) The adjudicator must provide a report to the Secretary of State and the sponsor, setting out any recommendations in respect of the disputed refusal.

(3) The Secretary of State must take the report of the adjudicator into account and decide whether to—

(a) confirm or alter the grounds for the refusal of the application,

(b) authorise the performance study, or

(c) in the case of a refusal under Article 66(3), proceed to consider the application under Article 66.

(4) The Secretary of State must notify the sponsor of the decision in paragraph (3).

(5) The sponsor must pay any fees, costs and expenses of the Institute and its appointed adjudicator that are payable in connection with the application made under paragraph (1).

Damage compensation in relation to performance studies

17E.    A sponsor of a performance study must hold sufficient insurance (or equivalent financial resources) to meet any potential financial liability in the event of injury or death attributable to participation in the performance study.

Retention of documentation relating to performance studies

17F.— (1)  The liquidator or trustee in bankruptcy of a sponsor of a performance study, or of a sponsor’s legal representative or contact person under Article 58(4), must—

(a) retain for the required period any documentation that consists of, or reasonably could consist of, any of the documentation referred to in Annex XIV, and

(b) comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.

(2) In this regulation, the required period is—

(a) in the case of documentation relating to the performance study of a device that was subsequently placed on the market, 10 years after the last device was placed on the market;

(b) in any other case, 10 years after the performance study ended.”.

Amendment to Part 4

37.  In the heading of Part 4, after “Regulation (EU) 2017/745” insert “and Regulation (EU) 2017/746”.

Amendment to regulation 18 (notified bodies)

38.  In regulation 18—

(a) in paragraph (1), after “Article 35” insert “of Regulation (EU) 2017/745 and Article 31 of Regulation (EU) 2017/746”;

(b) in paragraph (2), after “Article 46(6)” insert “of Regulation (EU) 2017/745 and Article 42(6) of Regulation (EU) 2017/746”.

Amendment to regulation 19 (fees payable in connection with the designation of notified bodies)

39.  In regulation 19—

(a) in paragraph (2)—

(i) in sub-paragraph (a), after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;

(ii) in sub-paragraph (b), after “Article 44(10)” insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”;

(iii) in sub-paragraph (c), after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”;

(b) in paragraph (3) after “under Article 42” insert “of Regulation (EU) 2017/745”;

(c) in paragraph (8)(a), after “Article 42” insert “of Regulation (EU) 2017/745 or Article 38 of Regulation (EU) 2017/746”.

Amendment to regulation 20 (language requirements)

40.  In regulation 20 for “provides” substitute “or Regulation (EU) 2017/746 provide”.

Amendment to regulation 23 (offence of breaching certain provisions)

41.  For regulation 23(1) substitute—

“(1) A person commits an offence if the person contravenes a prohibition or fails to comply with a requirement in a provision of—

(a) the regulations listed in Table 1;

(b) the articles of Regulation (EU) 2017/745 listed in Table 2;

(c) the articles of Regulation (EU) 2017/746 listed in Table 3;

in Schedule 3 to these Regulations.”.

Amendment to regulation 26 (enforcement)

42.  In regulation 26—

(a) in paragraph (1), for “and Regulation (EU) 2017/745” substitute “, Regulation (EU) 2017/745 and Regulation (EU) 2017/746”;

(b) in paragraph (2), for “and Regulation (EU) 2017/745” substitute “, Regulation (EU) 2017/745 and Regulation (EU) 2017/746”.

Amendment to Schedule 2 (fees in connection with the designation of notified bodies)

43.  In Schedule 2—

(a) the first column (application) in Table 1 (application fees) is amended as follows—

(i) at the end of entry 1 insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;

(ii) in entry 2, after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;

(iii) at the end of entry 3 insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”;

(iv) in entry 4—

(aa) after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”;

(bb) after “an Annex” insert “to Regulation (EU) 2017/745 or Regulation (EU) 2017/746”;

(v) in entry 5, after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”;

(b) the first column (activity) in Table 2 (fees for assessments and reviews) is amended as follows—

(i) in entry 1—

(aa) after “Article 39(4)” insert “of Regulation (EU) 2017/745 or Article 35(4) of Regulation (EU) 2017/746”;

(bb) after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;

(cc) at the end insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”;

(ii) at the end of entry 2 insert “of Regulation (EU) 2017/745 or Article 40(4) of Regulation (EU) 2017/746”;

(iii) at the end of entry 3 insert “of Regulation (EU) 2017/745 or Article 40(5) of Regulation (EU) 2017/746”;

(iv) in entry 5—

(aa) after “Article 44(7)” insert “of Regulation (EU) 2017/745 or Article 40(7) of Regulation (EU) 2017/746”;

(bb) in sub-paragraph (b), after “Regulation (EU) 2017/745” insert “, or Regulation (EU) 2017/746”.

Amendment to Schedule 3 (provisions breach of which is an offence under regulation 23)

44.  In Schedule 3—

(a) for Table 1 substitute—

“Table 1

Regulation	Title of the regulation
5	Reprocessing of single-use devices
6	Requirement on health institutions relating to implanted devices
7	Provision of information relating to custom-made devices
9	Retention of documentation relating to conformity assessments and custom-made devices
10	UK(NI) indication under Regulation (EU) 2017/745
10B	Retention of documentation relating to conformity assessments
10C	UK(NI) indication under Regulation (EU) 2017/746
11	Ethical review of clinical investigations
12(1)	Prior authorisation of clinical investigations by the Secretary of State
14	Damage compensation in relation to clinical investigations
15	Retention of documentation relating to clinical investigations
17C	Ethical review of performance studies
17E	Damage compensation in relation to performance studies
17F	Retention of documentation relating to performance studies”

(b) in Table 2—

(i) for “general obligations on manufacturers” substitute “general obligations of manufacturers”;

(ii) for “32(1), (2)” substitute “32(1) (except the second sentence of the third sub-paragraph), (2)”;

(iii) for “86” substitute “86 (except the second and third sentences of paragraph (2))”;

(c) after Table 2 insert—

“Table 3

Article	Title of the article
5(1) to (3), (5)	Placing on the market and putting into service
6(1) to (3)	Distance sales
7	Claims
9(3)	Common specifications
10 (except the second, third or fourth sub-paragraphs of paragraph 13)	General obligations of manufacturers
11(1), (3), (6)	Authorised representative
12	Change of authorised representative
13	General obligations of importers
14	General obligations of distributors
15	Person responsible for regulatory compliance
16(3), (4)	Cases in which obligations of manufacturers apply to importers, distributors or other persons
20(1)	Parts and components
22	Identification within the supply chain
29(1) (except the second sentence of the third sub-paragraph), (2)	Summary of safety and performance
48(1), (2), (3) (except the third sub-paragraph), (4) (except the second sub-paragraph), (7) (except the third sub-paragraph), (8) (except the second sub-paragraph), (9) and (10)	Conformity assessment procedures
49(3)	Involvement of notified bodies in conformity assessment procedures
53(1)	Voluntary change of notified body
57	General requirements regarding performance studies
58(1), (2), (4) (except the second sub-paragraph), (5), (6) and (8)	Additional requirements for certain performance studies
79	Post-market surveillance plan
80	Post-market surveillance report
81 (except the second and third sentences of paragraph (2))	Periodic safety update report
84(1), (3) (except the first sub-paragraph), (5) and (8)	Analysis of serious incidents and field safety corrective actions
89 (only the final paragraph)	Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance”.

(1)

S.I. 2021/905.

(2)

S.I. 2020/1460.