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The Medical Devices (Amendment) (Great Britain) Regulations 2023

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Amendments to regulation 44ZA (obligations in Part IV which are met by complying with obligations in Directive 98/79)

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9.—(1) Regulation 44ZA(1) is amended as follows.

(2) In paragraph (1)(a) for “amended from time to time” substitute “it had effect on 25 May 2022”.

(3) In paragraph (3)—

(a)at the beginning insert “Subject to to paragraph (3A),”;

(b)after sub-paragraph (b) insert—

“(ba)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 110(2) of Regulation (EU) 2017/746;”;

(c)in sub-paragraph (f) for “draws up” substitute “has drawn up before 26 May 2022”.

(4) After paragraph (3) insert—

“(3A) Paragraph (3) only applies to a relevant device for which the conformity assessment procedure under Article 9 did not require the involvement of a notified body, if the conformity assessment procedure for that device under Article 48 of Regulation (EU) 2017/746 would require the involvement of a notified body.”.

(1)

Regulation 44ZA was inserted by S.I. 2019/791.

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