# The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 20: Insertion of regulation 4(7D)


After regulation 4(7C) insert—
“(7D) In regulation 16 (procedures for general medical devices for clinical investigation)—
(a) for “his authorised representative” each time those words occur, substitute “their UK responsible person”;
(b) in paragraph (1), for “the United Kingdom” substitute “Great Britain”;
(c) in paragraph (2)—
(i) for “CE marking” substitute “UK marking”;
(ii) for “CE marked” substitute “UK marked”;
(d) in paragraph (4) for “or authorised representative” substitute “or UK responsible person”;
(e) in paragraph (11) for “single authorised representative” substitute “single UK responsible person”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348214956/schedule/2/paragraph/20 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-20
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.