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Paragraph 30A F1

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

(1)

The power in sub-paragraph (2) is available to an officer of a domestic enforcer acting F2pursuant to—

(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.

(F43)

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.

Annotations

Textual amendments

F1

Sch. 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)

F2

Words 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)

F3

Words 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)

F4

Sch. 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)

F5

Words 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)

Notes on Schedule 5

Modifications

C1

Sch. 5 applied (with modifications) (8.12.2016) by The Electromagnetic Compatibility Regulations 2016 (S.I. 2016/1091), reg. 1, Sch. 7 para. 3 (with regs. 74, 75(5))

C2

Sch. 5 applied (with modifications) (26.12.2017) by The Radio Equipment Regulations 2017 (S.I. 2017/1206), reg. 1, Sch. 10 para. 3 (with regs. 3-5, 77)

C3

Sch. 5: power to amend conferred (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 180(3)(a), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

Notes on Part 4

Textual amendments

F1

Words in Sch. 5 Pt. 4 heading substituted (31.12.2020) by The Consumer Protection (Enforcement) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/203), regs. 1, 4(7) (with reg. 9) (as amended by S.I. 2020/1347, regs. 1(3), 3(8)); 2020 c. 1, Sch. 5 para. 1(1)

F2

Word in Sch. 5 Pt. 4 heading substituted (6.4.2025) by Digital Markets, Competition and Consumers Act 2024 (c. 13), s. 339(1), Sch. 18 para. 11(7) (with Sch. 19); S.I. 2025/272, reg. 2(1)(9)

Modifications

C1

Sch. 5 Pt. 4: powers extended in part (1.1.2025) by Digital Markets, Competition and Consumers Act 2024 (c. 13), ss. 319, 339(1); S.I. 2024/1226, regs. 1(2), 2(1)(4)