# The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, Regulation 9: Amendment of Part VII of the 2002 Regulations

Extent: E+W+S+N.I.

(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);
(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.”.
(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”;
(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 ”;
(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
Mutual Recognition Agreement countries
Regulation 1A
— Australia
— New Zealand
— Canada
— The United States of America
— The Swiss Confederation”.

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Source: https://www.legislation.gov.uk/uksi/2019/791/regulation/9 (the official version)
Page: https://openlegislation.uk/medical-devices-amendment-etc-eu-exit-regulations-2019/regulation-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.