# The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 14: Insertion of regulation 4(6A)


After regulation 4(6) insert—
“(6A) In regulation 10 (CE marking of general medical devices)—
(a) in the heading for “CE Marking” substitute “UK marking”;
(b) in paragraph (1)—
(i) in the opening words for “CE marking” substitute “UK marking”;
(ii) in sub-paragraph (a) for “Annex XII” substitute “Annex 2 of Regulation (EC) No 765/2008 ” ;
(iii) in sub-paragraph (c) for “notified body” substitute “approved body”;
(c) in paragraph (2)—
(i) in the opening words for “CE marking” substitute “UK marking”;
(ii) in sub-paragraph (a) for “Annex XII” substitute “Annex 2 of Regulation (EC) No 765/2008”;
(iii) in sub-paragraph (c) for “notified body” substitute “approved body”;
(d) in paragraph (3)—
(i) in the words before sub-paragraph (a), for “a CE marking, meeting the requirements set out in Annex XII” substitute “a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008”;
(ii) in the words following sub-paragraph (b)—
(aa) for “CE marking” substitute “UK marking”;
(bb) for “notified body” substitute “approved body”;
(e) in paragraph (4)—
(i) in the words before sub-paragraph (a), for “a CE marking, meeting the requirements set out in Annex XII” substitute “a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008”;
(ii) in the words following sub-paragraph (b)—
(aa) for “CE marking” substitute “UK marking”;
(bb) for “notified body” substitute “approved body”;
(f) in paragraph (5) in the words after sub-paragraph (c), for both references to “CE marking” substitute “UK marking”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348214956/schedule/2/paragraph/14 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-14
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.