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The Medical Devices (Amendment) (Great Britain) Regulations 2023
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- UK Statutory Instruments
- 2023 No. 627
- Regulation 7
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Amendments to regulation 19C (obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745)
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7.—(1) Regulation 19C(1) is amended as follows.
(2) After paragraph (3)(b) insert—
“(ba)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn;”.
(3) For paragraph (7) substitute—
“(7) This paragraph applies where, before a system or procedure pack is placed on the market, the person responsible for combining devices to produce that system or procedure pack—
(a)has complied with the relevant requirements of Article 22 including where that Article requires a conformity assessment in accordance with Annex IX or XI; and
(b)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn.”.
(1)
Regulation 19C was inserted by S.I. 2019/791.
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