# The Medical Devices (Amendment) (Great Britain) Regulations 2023, Regulation 8: Amendments to regulation 30A (obligations in Part III which are met by complying with obligations in Directive 90/385)


(1) Regulation 30A is amended as follows.
(2) In paragraph (1)(a)—
(a) after “Directive 90/385” insert “as it had effect on 25 May 2021”;
(b) omit “as amended from time to time”.
(3) In paragraph (3)—
(a) after sub-paragraph (b) insert—
“(ba) ensures that the certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;”;
(b) in sub-paragraph (f) for “draws up” substitute “has drawn up before 26 May 2021”.

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Source: https://www.legislation.gov.uk/ukdsi/2023/9780348247657/regulation/8 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-amendment-great-britain-regulations-2023/regulation-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

