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

Amendment of Part VII of the 2002 Regulations U.K.

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) M2 In 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 2 U.K. Mutual Recognition Agreement countries

• — Australia

• — New Zealand

• — Canada

• — The United States of America

• — The Swiss Confederation”.

Textual Amendments

F1 Reg. 9(3)(d) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 2 para. 8; 2020 c. 1, Sch. 5 para. 1(1)

F2 Reg. 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

F3 Reg. 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

F4 Reg. 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

I1 Reg. 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)

I2 Reg. 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

M1 Regulation 59 was amended by S.I. 2003/1697.

M2 Regulation 60 was amended by S.I. 2008/2936.

M3 Regulation 63 was amended by S.I. 2008/2936.

M4 Regulation 67 was inserted by S.I. 2013/2327.

M5 Schedule 1 was amended by 2013/2327.

M6 Schedule 2 was amended by S.I. 2013/2327.