(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.

Review

67

Before the end of 31st December 2025, 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

5

The agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment signed in Luxembourg on 21st June 1999.

Expiry of certain provisions in these Regulations

1ZA

(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);

(d) regulation 44ZA(4) and (5);

(e) regulation 44ZB(4) and (5).

Schedules

1A

Schedules 2 and 2A have effect.

Interpretation

Medical devices which are qualifying Northern Ireland goods

2A

(1) Subject 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—

(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) 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.

(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.

(2) In this regulation,

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

(b) “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 Regulations

Designated standard

3A

(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 or 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

(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);

(3A) 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 such technical specifications adopted by the other recognised standardisation bodies or 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.

Confidentiality

3B

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

Transitional provisions

Transitional provisions for hip, knee and shoulder replacements

Revocations, transitional and saving provisions in respect of the new national registration requirements

4D

(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 date

4H

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

Revocation of Commission Decision 2010/227

4I

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

Revocation of Regulation (EU) No 207/2012 on 26th May 2025 and its effect before that date

4J

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

Revocation of Regulation (EU) No 722/2012 on 26th May 2025 and its effect before that date

4K

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

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

4L

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

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

4M

(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 2005/50

4N

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

Revocation of Regulation (EU) 2017/745

4O

(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) 2017/746

4P

(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 98/79

4T

(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) 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 ...;

(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).

UK marking of general medical devices

UK(NI) indication: general medical devices

10A

(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.

(3A) 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.

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

Exemptions from regulations 8 and 10

Procedures for affixing a UK marking to general medical devices

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

Procedures for custom-made general medical devices

Procedures for general medical devices for clinical investigations

Manufacturers etc. and conformity assessment procedures for general medical devices

Approved bodies and the conformity assessment procedures for general medical devices

Registration of persons placing general medical devices on the market

Additional requirements relating to use of animal tissues

Obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42

19B

(1) In this regulation—

(a) “the Directive” means Directive 93/42 as 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 ...;

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

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