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

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Amendment of Part VII of the 2002 RegulationsU.K.

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

(2) In regulation 59 M1(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) M2In regulation 60 (designation etc. of authorised representatives)—

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

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

(c)for paragraph (3), substitute—

“(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.”.

[F1(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 ”.]

[F2(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”;

(c)in paragraph (8)(a)(ii), omit “set out in the Medical Devices Directives”;

(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 ”;

[F3(iii)in sub-paragraph (c) omit “and, where applicable any relevant provision of the Medical Devices Directives”.]

(6) In regulation 63 M3 (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 ”.

[F4(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 M4 (review), for “2019” substitute “ 2025 ”.

(9) Omit Schedule 1 M5 (association agreements).

(10) For Schedule 2 M6 (mutual recognition agreements) substitute—

Regulation 1A

“SCHEDULE 2U.K.Mutual Recognition Agreement countries

  • — Australia

  • — New Zealand

  • — Canada

  • — The United States of America

  • — The Swiss Confederation”.

Textual Amendments

F2Reg. 9(4) substituted (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 2 para. 51

F3Reg. 9(5)(iii) inserted (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 2 para. 52

F4Reg. 9(6A) inserted (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 2 para. 53

Commencement Information

I1Reg. 9(1)(3)-(10) in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)

I2Reg. 9(2) in force at 1.5.2021, see reg. 1(2)(e) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2(c))

Marginal Citations

M1Regulation 59 was amended by S.I. 2003/1697.

M2Regulation 60 was amended by S.I. 2008/2936.

M3Regulation 63 was amended by S.I. 2008/2936.

M4Regulation 67 was inserted by S.I. 2013/2327.

M5Schedule 1 was amended by 2013/2327.

M6Schedule 2 was amended by S.I. 2013/2327.

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