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The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Type Statutory-Instrument

Publication 2019-04-01

Last updated 2021-05-01

State In force

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(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 amended from time to time; (b) “Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it applies in the European Union; (c) “CE marking” means the CE marking required by Article 16 and shown in Annex X; (d) “harmonised standard” is to be construed in accordance with Article 5. (2) Where paragraph (3) applies regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied. (3) 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; (c) ensures that the documentation required by the relevant conformity assessment procedure is drawn up; (d) ensures that the technical and other relevant documentation required by a relevant conformity assessment procedure is prepared in or translated into English; (e) affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes III, IV, V, VI or VII; (f) draws up an EU Declaration of Conformity in accordance with Article 9; (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 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”. (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; (c) “harmonised standard” has the meaning given in Article 2(73); (d) “sponsor” has the meaning given in Article 2(57). (2) Where paragraph (3) applies, regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied. (3) This paragraph applies where, before placing a relevant device on the market, the manufacturer— (a) ensures— (i) that the device meets the general safety and performance requirements in Annex I which apply to it; or (ii) that paragraphs (6) and (7) apply; (b) ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 48; (c) ensures that the documentation required by the relevant conformity assessment procedure is drawn up; (d) ensures that the technical documentation required by Annexes II and III and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English; (e) affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedures set out in Annexes IX, X and XI; (f) draws up an EU declaration of conformity in accordance with Article 17; and (g) ensures that the declaration of conformity is prepared in or translated into English. (4) Where paragraph (5) applies, regulation 43 is treated as being satisfied. (5) This paragraph applies where, before a person supplies or makes available a device falling within Part IV for the purposes of performance evaluation, the sponsor of the performance evaluation— (a) has been able to provide the Secretary of State with the required notice in the form of the application required by Chapter I of Annex XIV in English; (b) has been able to provide the Secretary of State with an undertaking to keep available information contained in the application in accordance with Chapter II of Annex XIV. (6) Where paragraph (7) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirements referred to in regulation 35(3) and (4). (7) This paragraph applies where— (a) a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard; or (b) a relevant device is in conformity with a common technical specification. (8) For the purpose of this regulation,in regulations 36(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.

Amendment of Part V of the 2002 Regulations

7

(1) Part V of the 2002 Regulations is amended as follows.

(2) In the Part V heading for “Notified Bodies” substitute “Approved Bodies”.

(3) Before regulation 45 insert—

(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.”.

(4) In regulation 45 (designation etc. of UK notified bodies)—

(a) in the heading for “UK notified bodies” substitute “approved bodies”;

(b) in paragraph (1)—

(i) for “article 11 of Directive 90/385, article 16 of Directive 93/42 or article 15 of Directive 98/79” substitute “these Regulations”;

(ii) for “a notified body” substitute “an approved body”;

(iii) for “a “UK notified body”” substitute “an “approved body””;

(d) in paragraph (2)(a)—

(i) for “Directive 90/385” substitute “Part III”;

(ii) for “notified bodies set out in Annex 8 of that Directive” substitute “approved bodies set out in Annex 8 of Directive 90/385”;

(e) in paragraph (2)(b)—

(i) for “Directive 93/42” substitute “Part II”;

(ii) for “notified bodies set out in Annex XI of that Directive” substitute “approved bodies set out in Annex XI of Directive 93/42”;

(f) in paragraph (2)(c)—

(i) for “Directive 98/79” substitute “Part IV”;

(ii) for “notified bodies set out in Annex IX of that Directive” substitute “approved bodies set out in Annex IX of Directive 98/79”;

(g) in paragraph (2)(d) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;

(h) in paragraph (4) for “a UK notified body” substitute “an approved body”;

(i) in paragraph (5)(c) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;

(j) in paragraph (6)—

(i) for “the notified body’s request” substitute “the approved body’s request”;

(ii) for “notified body” substitute “approved body”;

(k) in paragraph (7), in the opening words, for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;

(l) in paragraph (8)—

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

(ii) in sub-paragraph (b) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”.

(5) In regulation 46 (choice of notified bodies and conformity assessment bodies)—

(a) for the heading substitute “Choice of approved bodies and conformity assessment bodies”;

(b) for “a notified body” substitute “an approved body”

(d) for “any notified body” substitute “any approved body”.

(6) In regulation 47 (general matters relating to UK notified bodies)—

(a) for the heading substitute “General matters relating to approved bodies”;

(b) in paragraph (1)—

(i) for “A UK notified body” substitute “An approved body”;

(ii) for “his authorised representative” substitute “the manufacturer’s UK responsible person”;

(iii) for “a notified body” substitute “an approved body”;

(iv) for “the Medical Devices Directives” substitute “these Regulations”;

(i) for “his authorised representative” substitute “the manufacturer’s UK responsible person”;

(ii) for “a UK notified body” substitute “an approved body”;

(d) in paragraph (3)—

(i) for “his authorised representative supplies to a notified body” substitute “the manufacturer’s UK responsible person supplies to an approved body”;

(ii) for “the Medical Devices Directives” substitute “these Regulations”;

(iii) omit “if the notified body is within the United Kingdom”;

(iv) omit “or some other Community language acceptable to the notified body concerned”;

(e) in paragraph (4)—

(i) for “A UK notified body” substitute “An approved body”;

(ii) for “other notified bodies” substitute “other approved bodies”;

(f) in paragraph (5)—

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

(ii) in sub-paragraph (a) for “the Medical Devices Directives” substitute “these Regulations”;

(iii) in the words after sub-paragraph (b) for “notified body”, both times those words occur, substitute “approved body”;

(g) in paragraph (6)—

(i) for “a UK notified body” substitute “an approved body”;

(ii) for “the Mutual Recognition Agreements” in both places substitute “a mutual recognition agreement”;

(h) in paragraph (8)—

(i) for “A UK notified body” substitute “an approved body”;

(ii) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”.

(7) After regulation 47 insert—

(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).

(8) In regulation 48 (designation etc. of EC conformity assessment bodies)—

(a) in the heading omit “EC”;

(b) in paragraph (1)—

(i) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;

(ii) omit “European Community”;

(iii) for “an “EC CAB”” substitute “a “CAB””;

(i) for “an EC CAB” in both places substitute “a CAB”;

(ii) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;

(d) in paragraph (4) for “an EC CAB” substitute “a CAB”;

(e) in paragraph (5)(b)—

(i) for “an EC CAB” substitute “a CAB”;

(ii) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;

(f) in paragraph (6) omit “EC” in both places;

(g) in paragraph (7), in the opening words—

(i) for “an EC CAB” substitute “a CAB”;

(ii) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;

(h) in paragraph (8)—

(i) for “an EC CAB” in both places substitute “a CAB”;

(ii) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”.

(9) In regulation 49 (fees charged by UK notified bodies and EC conformity assessment bodies)—

(a) for the heading substitute “Fees charged by approved bodies and conformity assessment bodies”;

(b) in paragraph (1), in the opening words for “A UK notified body or EC CAB” substitute “An approved body or CAB”;

(a) in the case of an approved body, performing the functions of an approved body or an importing Party under these Regulations or a mutual recognition agreement; and

(d) in paragraph (1)(b)—

(i) for “an EC CAB” in both places it occurs substitute “a CAB”;

(ii) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;

(e) in paragraph (3)—

(i) in the opening words for “UK notified body or EC CAB” substitute “approved body or CAB”;

(ii) in sub-paragraph (a) for “notified body” substitute “approved body”;

(f) in paragraph (4) for “UK notified body or EC CAB” substitute “approved body or CAB”.

(10) In regulation 50 (products incorrectly marked with a notified body or conformity assessment body number)—

(a) in the heading for “a notified body” substitute “an approved body”;

(b) in paragraph (1) for “a notified body” in each place it occurs substitute “an approved body”;

(i) for “a notified body” each place it occurs substitute “an approved body”;

(ii) in sub-paragraph (b) for “the notified body” substitute “the approved body”;

(d) in paragraph (3)(a) for “a notified body” substitute “an approved body”;

(e) in paragraph (3)(b) for “notified body” in both places substitute “approved body”;

(f) in paragraph (4) for “a notified body” substitute “an approved body”.

(11) In regulation 51 (products incorrectly marked with a CE marking) and in the heading, for “CE marking” in each place it occurs substitute “UK marking”.

Amendment of Part VI of the 2002 Regulations

8

(1) Part VI of the 2002 Regulations is amended as follows.

(2) In regulation 53 (fees in connection with the registration of devices and changes in registration details) for “regulation 19 or 44” substitute “regulation 7A, 19, 21A, 33A or 44”.

(3) In regulation 54 (fees payable in connection with the designation of UK notified bodies)—

(a) for the heading substitute “Fees payable in connection with the designation of approved bodies”;

(b) in paragraph (1) for “a notified body” substitute “an approved body”;

(d) in paragraph (3C) for “A UK notified body” substitute “An approved body”;

(e) in paragraph (3D)—

(i) for “a UK notified body” substitute “an approved body”;

(ii) for “the UK notified body” substitute “the approved body”;

(f) in paragraph (3E) for “A UK notified body” substitute “An approved body”.

(4) In regulation 55 (fees payable in connection with the designation etc. of EC conformity assessment bodies)—

(a) in the heading omit “EC”;

(b) in paragraph (1), for “an EC CAB” substitute “ a CAB ”;

(i) for “an EC CAB” substitute “ a CAB ”;

(ii) for “the Mutual Recognition Agreements” substitute “ a mutual recognition agreement ”.

(4A) In regulation 56 (fees payable in relation to clinical investigation notices), in paragraph (2), for “his authorised representative” substitute “their UK responsible person”.

(5) In regulation58 (waivers, reductions and refunds)—

(a) in paragraph (2)(b)(i) for “a notified body” substitute “an approved body”;

(b) in paragraph (2)(b)(ii) for “an EC CAB” substitute “a CAB”.

Amendment of Part VII of the 2002 Regulations

9

(1) Part VII of the 2002 Regulations is amended as follows.

(2) In regulation 59 (interpretation of Part VII)—

(a) omit the definition of “registrable device”;

(b) in the definition of “relevant device” after “IV” insert “ or a device for the purposes of Part VIII or IX. ”.

(3) In regulation 60 (designation etc. of authorised representatives)—

(a) for the heading substitute “ Status of UK responsible person ”;

(b) omit paragraphs (1) and (2);

(3) A UK responsible person— (a) may be proceeded against as a person placing the device on the market for the purposes of these regulations; (b) in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market.

(d) in paragraph (4)—

(i) for “an authorised representative of a manufacturer of a device” substitute “ a UK responsible person ”;

(ii) for “the single authorised representative of the manufacturer” substitute “ a UK responsible person ”.

(4) In regulation 61 (enforcement etc.)—

(a) for “CE marking” in both places substitute “UK marking”;

(b) in paragraph (8)(a)(i), after “essential requirement” insert “, a general safety and performance requirement”;

(d) in paragraph (8)(a)(ii)(aa), for “his authorised representative” substitute “their UK responsible person”.

(5) In regulation 62 (compliance notices) in paragraph (1)—

(i) after “performance evaluation” insert “ or study ”;

(ii) for “the manufacturer or his authorised representative” substitute “ any person ”;

(iii) in sub-paragraph (c) omit “and, where applicable any relevant provision of the Medical Devices Directives”.

(6) In regulation 63 (restriction notices) in paragraph (1)—

(i) in sub-paragraph (a), after “performance evaluation” insert “ or study ”;

(ii) in sub-paragraph (b), after “performance evaluation” insert “ or study ”.

(6A) In regulation 64 (notification of decisions etc)—

(a) in paragraph (1)(c), for “him or his authorised representative” substitute “the applicant or the applicant’s UK responsible person”;

(b) in paragraph (2)—

(i) for “a UK notified body” substitute “an approved body”;

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

(7) Omit regulation 65(centralised system of records etc.).

(8) In regulation 67 (review), for “2019” substitute “ 2025 ”.

(9) Omit Schedule 1 (association agreements).

(10) For Schedule 2 (mutual recognition agreements) substitute—

SCHEDULE 2 - — Australia - — New Zealand - — Canada - — The United States of America - — The Swiss Confederation

PART 2 — New Part VIII of the Medical Devices Regulations

10

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

PART 3 — New part IX of the Medical Devices Regulations

11

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

PART 4 — New Schedules to the 2002 Regulations

12

After Schedule 2 to the 2002 Regulations insert—

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