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
— Australia
— New Zealand
— Canada
— The United States of America
— The Swiss Confederation”.
Textual Amendments
F1Reg. 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)
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)
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.