# The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 51: Substitution of regulation 9(4)


For regulation 9(4) substitute—
“(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”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348214956/schedule/2/paragraph/51 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-51
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.