Paragraph 16 Power to decommission or switch off any medical deviceI1

Northern Ireland

(1)

The power in sub-paragraph (2) is available to an officer of an enforcer acting F1pursuant to—

(a)

the duty in regulation 61(1A) or (1B) of the Medical Devices Regulations 2002,

(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(1) or (2) of the Medical Devices (Northern Ireland Protocol) Regulations 2021.

F2(2)

The officer may decommission or switch off any medical device to which the Medical Devices Regulations 2002, Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices apply which is installed at a given location.

(3)

An enforcer may exercise the power in this paragraph—

(a)

if an officer of the enforcer reasonably suspects a contravention of an obligation on an economic operator under any of—

(i)

the Medical Devices Regulations 2002;

(ii)

regulations made under section 15(1) of the Medicines and Medical Devices Act 2021; F3...

F4(iii)

the Medical Devices (Northern Ireland Protocol) Regulations 2021;

(iv)

Regulation (EU) 2017/745 on medical devices; F5...

F6(v)

Regulation (EU) 2017/746 on in vitro diagnostic medical devices; and

(b)

for the purpose of ascertaining (by means of testing or otherwise) whether there has been such non-compliance.

Annotations

Textual amendments

F1: Words in Sch. 1 para. 16(1) substituted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 43(3)(b)(i)
F2: Sch. 1 para. 16(2) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 26(b)(i)
F3: Word in Sch. 1 para. 16(3)(a)(ii) omitted (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 43(3)(b)(iii)
F4: Sch. 1 para. 16(3)(a)(iii)(iv) inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 43(3)(b)(iv)
F5: Word in Sch. 1 para. 16(3)(a)(iv) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 26(b)(ii)
F6: Sch. 1 para. 16(3)(a)(v) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 26(b)(ii)

Commencement

I1: Sch. 1 para. 16 in force at 16.7.2021, see reg. 1(1)