[F130A(1)The power in sub-paragraph (2) is available to an officer of a domestic enforcer acting [F2pursuant to— U.K.
(a)the duty in regulation 61(1A) or (1B) of the Medical Devices Regulations 2002 (S.I. 2002/618),
(b)a duty in regulations made under section 15(1) of the Medicines and Medical Devices Act 2021, or
(c)the duty in regulation 26 of the Medical Devices (Northern Ireland Protocol) Regulations 2021.]
(2)The officer may decommission or switch off any [F3relevant medical device] which is installed at a given location.
[F4(3)In sub-paragraph (2), “relevant medical device” means—
(a)where a domestic enforcer is acting pursuant to a duty mentioned in sub-paragraph (1)(a) or (b), any medical device to which the Medical Devices Regulations 2002 apply;
(b)where a domestic enforcer is acting pursuant to the duty mentioned in sub-paragraph (1)(c), any medical device to which Regulation (EU) 2017/745 on medical devices [F5or Regulation (EU) 2017/746 on in vitro diagnostic medical devices] applies.]]
Textual Amendments
F1Sch. 5 para. 30A inserted (26.5.2021) by Medicines and Medical Devices Act 2021 (c. 3), ss. 41(2)(d), 50(3); S.I. 2021/610, reg. 2(c) (with reg. 3)
F2Words in Sch. 5 para. 30A(1) substituted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 27(5)(a)
F3Words in Sch. 5 para. 30A(2) substituted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 27(5)(b)
F4Sch. 5 para. 30A(3) inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 27(5)(c)
F5Words in Sch. 5 para. 30A(3)(b) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 4(c)