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The Medical Devices Regulations 2002

Type Statutory-Instrument

Publication 2002-05-20

Last updated 2026-04-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Reform history JSON API

[^key-e40b6588bbd062f77bb394af03029ee0]: Reg. 53(2)-(7) inserted (N.I.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 4(c)

[^key-ebb2c3b3cd0ae0da2d75a4f268636c09]: Sum in reg. 53(1) substituted (N.I.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 4(b)

Interpretation of Part V

44A

In this Part, “medical device” means a device that is a “relevant device” for the purposes of Part II, III or IV.

Designation etc. of UK notified bodies

Choice of notified bodies and conformity assessment bodies

General matters relating to UK notified bodies

Designation etc. of EC conformity assessment bodies

Fees charged by UK notified bodies and EC conformity assessment bodies

Products incorrectly marked with a notified body or conformity assessment body number

Products incorrectly marked with a CE marking

Additional requirements relating to use of animal tissues

19A

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Transitional provisions for hip, knee and shoulder replacements

4A

(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.

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

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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

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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

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

4K

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

4L

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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

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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;

(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) Subject 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;

(ba) 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;

(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) has 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.

(3A) 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;

(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;

(ba) 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;

(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 English; and

(e) 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) 2017/745

19C

(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;

(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;

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

(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.

(7) 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”.

Registration of persons placing active implantable medical devices on the market

21B

(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;

(ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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;

(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.

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

21C

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Essential requirements for active implantable medical devices

Determining compliance of active implantable medical devices with relevant essential requirements

UK marking of active implantable medical devices

UK(NI) indication: active implantable medical devices

24A

(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.

(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 active implantable medical devices that come within the scope of this Part and other legislation

Exemptions from regulations 22 and 24

Procedures for affixing a UK marking to active implantable medical devices

Procedures for custom-made active implantable medical devices

Procedures for active implantable medical devices for clinical investigations

Manufacturers etc. and conformity assessment procedures for active implantable medical devices

Obligations in Part III which are met by complying with obligations in Directive 90/385

30A

(1) In this regulation—

(a) “the Directive” means Directive 90/385 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;

(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;

(ba) 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;

(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) has 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;

(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”.

Approved bodies and the conformity assessment procedures for active implantable medical devices

UK marking of in vitro diagnostic medical devices

UK(NI) indication: in vitro diagnostic medical devices

36A

(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.

(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 in vitro diagnostic devices that come within the scope of this Part and other legislation

In vitro diagnostic medical devices not ready for use

Exemptions from regulations 34, 36 and 38

Procedures for affixing a UK marking to in vitro diagnostic medical devices

Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices

Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices

Devices for performance evaluation

Registration of manufacturers etc. of in vitro diagnostic medical devices and devices for performance evaluation

Obligations in Part IV which are met by complying with obligations in Directive 98/79

44ZA

(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 it had effect on 25 May 2022;

(b) “Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it applies in the European Union;

(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) Subject 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;

(ba) 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;

(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) has 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.

(3A) 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”.

Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746

44ZB

(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;

(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;

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

(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”.

Meaning of approved body and UK notified body

A45

(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 approved bodies

Choice of approved bodies and conformity assessment bodies

General matters relating to approved bodies

Register of approved bodies

47A

(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).

Designation etc. of ... conformity assessment bodies

Fees charged by approved bodies and conformity assessment bodies

Products incorrectly marked with an approved body or conformity assessment body number

Products incorrectly marked with a UK marking

Status of UK responsible person

SCHEDULE 2 — Mutual Recognition Agreement countries

— Australia

— New Zealand

— Canada

— The United States of America

— The Swiss Confederation

SCHEDULE 2A — Modification of Annexes to Directives 90/385, 93/42, 98/79

PART 1 — Modification of Annexes to Directive 90/385

1

(1) The Annexes to Directive 90/385 are modified so that they read as if amended by paragraphs 2 to 10.

(2) In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002.

2

In Annex 1—

(za) in Section 2, for “the functions referred to in Article 1(2)(a)” substitute “the purposes referred to in the definition of a medical device in regulation 2(1) of the Regulations

(a) in Section 8 for the fifth indent substitute —

–risks connected with ionising radiation from radioactive substances included in the device,

(b) for Section 10 substitute—

(10) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in regulation 2 of the Human Medicines Regulations 2012, and which is liable to act upon the body with an action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC as modified by Schedule 8B to the Human Medicines Regulations 2012. For the substances referred to in the first paragraph, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing an opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body. Where a device incorporates, as an integral part, a human blood derivative, the approved body shall, having verified the usefulness of the substance as part of the device and taking into account the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing the opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body. Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the approved body shall be informed of the changes and shall consult the Secretary of State, in order to confirm that the quality and safety of the ancillary substance are maintained. The Secretary of State shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the approved body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device. When the Secretary of State has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, the Secretary of State shall provide the approved body with advice on whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The approved body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

(i) for “the name and address of the authorised representative” substitute “, where such a person is appointed under regulation 21A of the Regulations, the name and address of the UK responsible person,”;

(ii) for “the Community” substitute “the United Kingdom”;

(iii) for “a device within the meaning of Article 1(4a)” substitute “a stable derivatives device

(d) in Section 15 in the first indent for “CE mark” substitute “UK mark”.

3

In Annex 2—

(a) for the heading substitute “Declaration of conformity”;

(b) for “the notified body” each time it occurs substitute “the approved body”;

(d) in Section 1, for “EC Surveillance” substitute “Surveillance”;

(e) in Section 2—

(i) for “his authorized representative” substitute “their UK responsible person”;

(ii) omit “established within the Community”;

(iii) for “CE marking” , in both places it occurs, substitute “UK marking”;

(iv) for “Article 12” substitute “regulation 24”;

(f) in Section 3.1—

(i) in the opening words, for “a notified body” substitute “an approved body”;

(ii) omit the fifth indent;

(g) in Section 3.2—

(i) in the first paragraph, omit “of this Directive”;

(ii) in point (c), for “Article 5” substitute “regulation 3A of the Regulations”;

(h) in Section 3.3—

(i) for the first sentence substitute—

The quality system shall be audited by an approved body to determine whether it meets the requirements referred to in Section 3.2.

(ii) in the second sentence for “harmonized” substitute “designated”;

(i) in Section 3.4, in the second paragraph, for the first sentence substitute—

The proposed modifications shall be evaluated by the approved body so as to verify whether the quality system so modified would still meet the requirements referred to in Section 3.2.

(j) in Section 4.2 in the second indent for “Article 5” substitute “regulation 3A of the Regulations”;

(k) for Section 4.3 substitute—

(4.3) The approved body must examine the application and, where the product complies with the relevant provisions of the Regulations, shall issue the applicant with a design certificate. The approved body may require the application to be supplemented by further tests or proof so that compliance with the requirements of the Regulations may be evaluated. The certificate shall contain conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product. In the case of devices referred to in Annex 1, Section 10, second paragraph, the approved body shall, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State. In the case of devices referred to in Annex I, Section 10, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.

(l) in Section 4.4, for each reference to “EC design” substitute “design”;

(m) in Section 6.1—

(i) for “national authorities” substitute “Secretary of State”;

(ii) for “his authorised representative” substitute “their UK responsible person”;

(n) for Section 6.2 substitute—

(6.2) On request, an approved body must make available to other approved bodies and to the Secretary of State all relevant information on approvals of quality systems, issued, refused or withdrawn.

(o) for Section 7 substitute—

(7) Application to the devices incorporating a human blood derivative: Upon completing the manufacture of each batch of devices incorporating a human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.

4

In Annex 3—

(a) in the title for “EC TYPE-EXAMINATION” substitute “TYPE-EXAMINATION”;

(b) for “EC type-examination” in each other place substitute “type-examination”;

(d) for “the notified body” in each place substitute “the approved body”;

(e) in Section 1, for “this Directive” substitute “the Regulations”;

(f) in Section 2—

(i) for the first sentence substitute—

The application for type-examination shall be made by the manufacturer to the approved body.

(ii) for “the authorized representative” substitute “the UK responsible person”;

(iii) for “this Directive” substitute “the Regulations”;

(g) in Section 3, for each reference to “Article 5” substitute “regulation 3A of the Regulations”;

(h) for Sections 4 and 5, substitute—

(4) The approved body shall— (4.1) examine and evaluate the documentation, verify that the type has been manufactured in accordance with that documentation; it shall also record the items which have been designed in accordance with the applicable provisions of the standards referred to in regulation 3A of the Regulations, as well as the items for which the design is not based on the relevant provisions of the said standards. (4.2) carry out or have carried out the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements where the standards referred to in regulation 3A of the Regulations have not been applied. (4.3) carry out or have carried out the appropriate inspections and the tests necessary to verify whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied. (4.4) agree with the applicant on the place where the necessary inspections and tests will be carried out. (5) Where the type meets the provisions of the Regulations, the approved body shall issue a type-examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, the conclusions of the control, the conditions under which the certificate is valid and the information necessary for identification of the type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept by the approved body. In the case of devices referred to in Annex I, Section 10, second paragraph, the approved body shall, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State. In the case of devices referred to in Annex I, Section 10, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.

(i) in Section 6 omit “EC” each time it occurs;

(j) for Section 7 substitute—

(7.1) On request, an approved body shall make available to other conformity assessment bodies (including other approved bodies) and to the Secretary of State all relevant information on type-examination certificates and addenda to those certificates issued, refused and withdrawn. (7.2) The approved body must cooperate with other approved bodies with regard to making available copies of the type examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer. (7.3) The manufacturer or their UK responsible person shall keep with the technical documentation a copy of the UK type-examination certificates and the supplements to them for a period of at least 15 years from the manufacture of the last product.

5

For Annex 4 substitute—

(1) Verification is the procedure whereby the manufacturer ensures and declares that the products subject to the provisions of Section 3 are in conformity with the type as described in the type-examination certification and satisfy the requirements of the Regulations that apply to them. (2) The manufacturer shall take all measures necessary in order that the manufacturing process ensures conformity of the products to the type as described in the type-examination certification and to the requirements of the Regulations that apply to them. The manufacturer shall affix the UK marking to each product and draw up a written declaration of conformity. (3) The manufacturer shall, before the start of manufacture, prepare documents defining the manufacturing processes, in particular as regards sterilization, together with all the routine, pre-established provisions to be implemented to ensure uniformity of production and conformity of the products with the type as described in the type examination certificate as well as with the relevant requirements of the Regulations. (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (5) The approved body must carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of the Regulations by examination and testing of products on a statistical basis, as specified in Section 6. The manufacturer must authorize the approved body to evaluate the efficiency of the measures taken pursuant to Section 3, by audit where appropriate. (6) Statistical verification (6.1) Manufacturers must present the products manufactured in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced. (6.2) A random sample must be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as set out in the standards referred to in regulation 3A of the Regulations, or equivalent tests must be carried out to verify their conformity to the type as described in the type-examination certificate and thereby determine whether a batch is to be accepted or rejected. (6.3) Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the designated standards referred to in regulation 3A of the Regulations, taking account of the specific nature of the product categories in question. (6.4) Where batches are accepted, the approved body shall affix, or cause to be affixed, its identification number to each product and draw up a written certificate of conformity relating to the tests carried out. All products in the batch may be placed on the market except for those products from the sample which were found not to be in conformity. Where a batch is rejected, the approved body shall take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches the approved body may suspend the statistical verification. The manufacturer may, with the agreement of the approved body, affix the approved body’s identification number during the manufacturing process. (6.5) The manufacturer or their UK responsible person must ensure that they are able to supply the approved body’s certificates of conformity on request. (7) Application to the devices incorporating human blood derivative: Upon completing the manufacture of each batch of devices incorporating human blood derivative the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.

6

For Annex 5, substitute—

(1) The manufacturer shall apply the quality system approved for the manufacture and must conduct the final inspection of the products concerned as specified in Section 3; the manufacturer shall be subject to the surveillance referred to in Section 4. (2) This declaration of conformity is the procedural element whereby the manufacturer who satisfies the obligations of Section 1 guarantees and declares that the products concerned conform to the type described in the type-examination certificate and meet the provisions of the Regulations which apply to them. The manufacturer must affix the UK marking in accordance with regulation 24 of the Regulations and draw up a written declaration of conformity. This declaration shall cover one or more devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer. The UK marking shall be accompanied by the identification number of the approved body responsible. (3) Quality system (3.1) The manufacturer shall make an application for evaluation of their quality system to an approved body. The application shall include: - all appropriate information concerning the products which it is intended to manufacture, - the quality-system documentation, - an undertaking to fulfil the obligations arising from the quality system as approved, - an undertaking to maintain the approved quality system in such a way that it remains adequate and efficacious, - where appropriate, the technical documentation relating to the approved type and a copy of the type-examination certificate, - ... (3.2) Application of the quality system must ensure that the products conform to the type described in the type-examination certificate. All the elements, requirements and provisions adopted by the manufacturer for their quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures. This quality-system documentation must make possible a uniform interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records. It shall include in particular an adequate description of— (a) the manufacturer’s quality objectives; (b) the organization of the business and in particular— - the organizational structures, the responsibilities of the managerial staff and their organizational authority where manufacture of the products is concerned, - methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of the products, including control of products which do not conform, - where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party; (c) the techniques of control and of quality assurance at the manufacturing stage and in particular— - the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents, - product identification procedures drawn up and kept up-to-date from drawings, specifications or other relevant documents at every stage of manufacture; (d) the appropriate tests and trials which will be effected before, during and after production, the frequency with which they will take place, and the test equipment used. (3.3) Without prejudice to regulation 50 of the Regulations, the approved body shall effect an audit of the quality system to determine whether it meets the requirements referred to in Section 3.2. It shall presume conformity with these requirements for the quality systems which use the corresponding harmonized standards. The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of the technology concerned. The evaluation procedure shall include an inspection on the manufacturer’s premises. The decision shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a reasoned evaluation. (3.4) The manufacturer shall inform the approved body which has approved the quality system of any plan to alter that system. The approved body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in Section 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions of the control and a reasoned evaluation. (4) Surveillance (4.1) The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations which arise from the approved quality system. (4.2) The manufacturer shall authorize the approved body to carry out all necessary inspections and shall supply it with all appropriate information, in particular— - the quality-system documentation, - the technical documentation, - the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardizations/ calibrations and the qualifications of the staff concerned, etc. (4.3) The approved body must periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report. (4.4) In addition, the approved body may make unannounced visits to the manufacturer, and must supply the manufacturer with an inspection report. (5) The approved body shall communicate to the other approved bodies all relevant information concerning approvals of quality systems issued, refused or withdrawn. (6) Application to the devices incorporating human blood derivative: Upon completing the manufacture of each batch of devices, incorporating human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.

7

In Annex 6—

(a) in Section 1, for “authorised representative established within the Community” substitute “UK responsible person”;

(b) in Section 3 for “the competent national authorities” substitute “the Secretary of State”;

(d) in Section 3.2 for the fourth indent substitute—

–the results of the risk analysis and a list of the designated standards provided for in regulation 3A of the Regulations, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements where the standards in regulation 3A of the Regulations have not been applied,

(e) omit Section 5.

8

In Annex 7—

(a) in Section 1.1 for “harmonised” substitute “designated”;

(b) in Section 2.3.5 for “all competent authorities of the Member States in which the clinical investigation is being performed” substitute “the Secretary of State”;

9

In Annex 8—

(a) in the title for “when designating inspection bodies to be notified” substitute “when designating approved bodies”;

(aa) in Section 1 for “authorized representative” substitute “UK responsible person”;

(b) in Section 3 omit the words “and for which it has been notified”;

(d) in Section 7 omit from “(except vis-à-vis”to the end.

10

Omit Annex 9.

PART 2 — Modification of Annexes to Directive 93/42

11

(1) The Annexes to Directive 93/42 are modified so that they read as if amended by paragraphs 12 to 23.

(2) In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002.

12

In Annex I—

(a) in Section 3, for “Article 1(2)(a)” substitute “regulation 2(1) of the Regulations”;

(b) in Section 7, for “notified body” each time it occurs substitute “approved body”;

(7.4) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in regulation 2 of the Human Medicines Regulations 2012, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I toDirective 2001/83/ECas modified by the Human Medicines Regulations 2012. For the substances referred to in the first paragraph, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing an opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body. Where a device incorporates, as an integral part, a human blood derivative, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing the opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body. Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the approved body must be informed of the changes and must consult the Secretary of State in order to confirm that the quality and safety of the ancillary substance are maintained. The Secretary of State must take account of the data related to the usefulness of incorporation of the substance into the device as determined by the approved body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device. When the Secretary of State has obtained information on an ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, the Secretary of State must provide the approved body with advice on whether this information has any impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The approved body must take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

(d) in Section 7.5—

(i) for the reference to “Annex 1 to Council Directive 67/548/EEC of 27 June 1967”, substitute “Regulation (EC) No. 1272/2008”;

(ii) for the reference to “Annex 1 to Council Directive 67/548/EEC”, substitute “the UK mandatory classification and labelling list established and maintained in accordance with Article 38A of Regulation 1272/2008”;

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