Statutory Instruments

2024 No. 221

Medical Devices

Consumer Protection

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

Made

22nd February 2024

Coming into force

21st March 2024

The Secretary of State, in exercise of the powers conferred by section 8C of, and paragraph 1(1)(ab) of Schedule 4, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018(1), makes the following Regulations.

The Treasury has consented to the making of these Regulations as required by paragraph 3(1) of Schedule 4 to that Act.

A draft of this instrument has been approved by a resolution of each House of Parliament, in accordance with paragraphs 8F(1)(2) and 12(1) of Schedule 7 to that Act.

PART 1Preliminary

Citation and commencement

1.—(1) These Regulations may be cited as the Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024.

(2) These Regulations come into force on the 28th day after the day on which they are made.

Extent and application

2.—(1) Subject to paragraphs (2) to (4), any amendment or revocation made by these Regulations has the same extent as the provision amended or revoked.

(2) Regulations 23, 33, 34 and 36 extend to Northern Ireland only.

(3) Regulation 9 applies in relation to Great Britain only.

(4) Regulations 10, 14 and 19 apply in relation to Northern Ireland only.

PART 2Amendments to primary legislation

Amendment to the Human Tissue Act 2004

3. In section 1(3) of the Human Tissue Act 2004(4) (authorisation of activities for scheduled purposes), in subsection (12), for paragraph (a), substitute—

“(a)the use of relevant material to the extent that such use is regulated by—

(i)the Medical Devices Regulations 2002 (S.I. 2002/618),

(ii)Regulation (EU) 2017/745(5) 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, or

(iii)Regulation (EU) 2017/746(6) 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, or”.

Amendment to the Consumer Rights Act 2015

4. In the Consumer Rights Act 2015(7), Schedule 5(8) (investigatory powers etc.) is amended as follows—

(a)in paragraph 8, after the definition of “Regulation (EU) 2017/745 on medical devices” insert—

““Regulation (EU) 2017/746 on in vitro diagnostic medical devices” 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;”;

(b)in paragraph 19(7A)(a)—

(i)at the end of sub-paragraph (iii), omit “or”;

(ii)at the end of sub-paragraph (iv), omit “and” and insert—

“or

(v)Regulation (EU) 2017/746 on in vitro diagnostic medical devices, and”;

(c)in paragraph 30A(3)(b), after “Regulation (EU) 2017/745 on medical devices” insert “or Regulation (EU) 2017/746 on in vitro diagnostic medical devices”.

Amendment to the Medicines and Medical Devices Act 2021

5. The Medicines and Medical Devices Act 2021(9) is amended in accordance with regulations 6 and 7.

Amendment to section 21 (compliance notices)

6. In section 21(10), in subsection (1A) for paragraph (d) substitute—

“(d)the EU Medical Devices Regulations.”.

Amendment to section 42 (interpretation of Part 4)

7. In section 42(11), in subsection (2), in the definition of “manufacturer”, for paragraph (b) substitute—

“(b)the EU Medical Devices Regulations;”.

PART 3Amendments to secondary legislation

Amendment to the Medical Devices Regulations 2002

8. The Medical Devices Regulations 2002(12) are amended in accordance with regulations 9 to 19.

Amendment to regulation 2 (interpretation) in relation to Great Britain

9. In regulation 2(1)(13) after the definition of “Regulation (EU) 2017/746” insert—

““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(14);”.

Amendment to regulation 2 (interpretation) in relation to Northern Ireland

10. In regulation 2(1)(15) after the definition of “Regulation (EU) 2017/745” insert—

““Regulation (EU) 2017/746” means Regulation (EU) 2017/746(16) 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(17);”.

Amendment to regulation 2A (medical devices which are qualifying Northern Ireland goods)

11. In regulation 2A(18)—

(a)in paragraph (1)—

(i)before “Notwithstanding” insert “Subject to paragraph (1A),”;

(ii)for sub-paragraph (a) substitute—

“(a)which meets the requirements of—

(i)these Regulations as they apply in Northern Ireland;

(ii)Regulation (EU) 2017/745; or

(iii)Regulation (EU) 2017/746; and”;

(b)after paragraph (1) insert—

“(1A) 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.”.

Amendment to regulation 3ZA (revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745)

12. In regulation 3ZA(19)—

(a)at the end of the heading insert “and Regulation (EU) 2017/746”;

(b)for paragraph (1) substitute—

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

(c)in paragraph (2)—

(i)omit “whether or not the device to which they apply is referred to in paragraph (1)”;

(ii)for sub-paragraph (a) substitute—

“(a)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;”;

(iii)in sub-paragraph (b) after “5 to 7” insert “also”;

(d)in paragraph (3)—

(i)for “For the purposes of paragraph (1)” substitute “For the purposes of this regulation”;

(ii)after “Regulation (EU) 2017/745” insert “or Article 110 of Regulation (EU) 2017/746”;

(iii)in sub-paragraph (a) for the words from “Directive 93/42” to the end, substitute “Directive 90/385, Directive 93/42 or Directive 98/79, rather than Regulation (EU) 2017/745 or Regulation (EU) 2017/746; and”;

(iv)in sub-paragraph (b), omit “, 3 and 5”.

Amendment to regulation 4T (references in other legislation to Directives 90/385, 93/42 and 98/79)

13. In regulation 4T(20), omit paragraph (1).

Revocation of regulation 19B (requirement to appoint a UK responsible person for general medical devices)

14. Omit regulation 19B(21).

Revocation of regulation 21C (requirement to appoint a UK responsible person for active implantable medical devices)

15. Omit regulation 21C(22).

Amendment to regulation 34A (approval requirement for coronavirus test devices)

16. In regulation 34A(23), in paragraphs (1) and (2), for “34B, 34C” substitute “34B to 34D”.

New regulation 34D (exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107)

17. After regulation 34C (transitional provisions for coronavirus test devices)(24) insert—

“Exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107

34D. 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.”.

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

18. In regulation 44(25)—

(a)omit paragraph (1)(a)(ii);

(b)omit paragraph (2)(c);

(c)omit paragraph (5);

(d)omit paragraph (6).

Revocation of regulation 44ZA (requirement to appoint a UK responsible person for placing in vitro diagnostic medical devices on the market or for performance evaluation)

19. Omit regulation 44ZA(26).

Amendment to the Blood Safety and Quality Regulations 2005

20. In the Blood Safety and Quality Regulations 2005(27), in regulation 2(28) (designation of the competent authority for Northern Ireland and scope of the Regulations) for paragraph (3) substitute—

“(3) These Regulations apply without prejudice to—

(a)the Medical Devices Regulations 2002,

(b)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, and

(c)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.”.

Amendment to the Human Tissue (Quality and Safety for Human Application) Regulations 2007

21. In the Human Tissue (Quality and Safety for Human Application) Regulations 2007(29), in regulation 2(30) (extent and application), paragraph (3) is amended as follows—

(a)at the end of sub-paragraph (d), omit “or”;

(b)at the end of sub-paragraph (e), insert—

“, or

(f)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.”.

Amendment to the Legislative and Regulatory Reform (Regulatory Functions) Order 2007

22. In the Legislative and Regulatory Reform (Regulatory Functions) Order 2007(31), in Part 2 of the Schedule(32), in the section headed “Medicines”, after “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” insert—

“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”.

Amendment to the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012

23.—(1) In the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012(33), regulation 2(34) (interpretation) is amended in accordance with this regulation.

(2) After the definition of “infringing EEE” insert—

““in vitro diagnostic medical device” has the meaning given in Article 2 of 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;”.

(3) For the definition of “medical device”, “active implantable medical device”, and “in vitro diagnostic medical device”, substitute—

““medical device” and “active implantable medical device” have the meanings given in regulation 2(1) of the Medical Devices Regulations 2002;”.

Amendment to the Waste Electrical and Electronic Equipment Regulations 2013

24. In the Waste Electrical and Electronic Equipment Regulations 2013(35), in regulation 2(36) (interpretation), for the definition of “in vitro diagnostic medical device”, substitute—

““in vitro diagnostic medical device” means an in vitro diagnostic device or accessory within the meaning of—

(a)

regulation 2(1) of the Medical Devices Regulations 2002 in relation to England and Wales and Scotland, and

(b)

Article 2 of 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 in relation to Northern Ireland,

which is EEE;.”.

Amendment to the Economic Growth (Regulatory Functions) Order 2017

25. In the Economic Growth (Regulatory Functions) Order 2017(37), in Part 3 of the Schedule(38), under the cross-heading “Medicines”, after “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” insert—

Amendment to the Market Surveillance (Northern Ireland) Regulations 2021

26. In the Market Surveillance (Northern Ireland) Regulations 2021(39), Schedule 1(40) (investigatory powers) is amended as follows—

(a)in paragraph 1, after the definition of “Regulation (EU) 2017/745 on medical devices” insert—

(b)in paragraph 16—

(i)for sub-paragraph (2) substitute—

“(2) The officer may decommission or switch off any medical device to which the Medical Devices Regulations 2002, Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices apply which is installed at a given location.”;

(ii)at the end of sub-paragraph (3)(a)(iv) omit “and” and insert—

“(v)Regulation (EU) 2017/746 on in vitro diagnostic medical devices; and”.

PART 4Amendments 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(41) 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(42).”;

(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 2AMaking 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 3APerformance 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,