[F1Medical devices which are qualifying Northern Ireland goodsE+W+S
2A.—(1) [F2Subject 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—
[F3(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.
[F4(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,
[F5(a)] “qualifying Northern Ireland good” has the meaning given in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;
[F6(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.]]
Textual Amendments
F1Reg. 2A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(4A) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 6); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in reg. 2A(1) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 11(a)(i)
F3Reg. 2A(1)(a) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 11(a)(ii)
F4Reg. 2A(1A) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 11(b)
F5Words in reg. 2A(2) renumbered as reg. 2A(2)(a) (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 31(b)(i)
F6Reg. 2A(2)(b) inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 31(b)(ii)