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The Medical Devices Regulations 2002

The Medical Devices Regulations 2002 reg 2A

reg 2A Medical devices which are qualifying Northern Ireland goods

(1) Subject to paragraph (1A), notwithstanding the effect of regulations 19B, 19C, 30A, 44ZA and 44ZB and the expiry of the period during which those regulations apply by virtue of regulation 1ZA, any medical device— (a) which meets the requirements of— (i) these Regulations as they apply in Northern Ireland; (ii) Regulation (EU) 2017/745 ; or (iii) Regulation (EU) 2017/746 ; and (b) which is a qualifying Northern Ireland good, may be placed on the Great Britain market as if it meets the requirements of these Regulations as they apply in Great Britain. (1A) Before 25 July 2024, paragraph (1) only applies to a coronavirus test device that meets the requirements of Regulation (EU) 2017/746 if the device also meets the requirements of— (a) regulation 34A (approval requirement for coronavirus test devices); or (b) the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107 . (2) In this regulation, (a) “qualifying Northern Ireland good” has the meaning given in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018; (b) “Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC , Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC .

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