1.—(1) These Regulations may be cited as the Medical Devices (Northern Ireland Protocol) Regulations 2021.
(2) These Regulations come into force on the day after the day on which they are made.
Commencement Information
I1Reg. 1 in force at 27.7.2021, see reg. 1(2)
2.—(1) Parts 1, 4, 5, 7 and 8 extend to England and Wales, Scotland and Northern Ireland.
(2) Parts 2, [F12A,] 3 [F2, 3A] and 6 extend to Northern Ireland only.
(3) Any amendment made by Part 9 has the same extent as the provision amended.
(4) In Part 8—
(a)Regulations 30, and 32 to 37 apply in relation to Northern Ireland only;
(b)Regulation 31 applies in relation to Great Britain only.
Textual Amendments
F1Word in reg. 2(2) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 28(a)
F2Word in reg. 2(2) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 28(b)
Commencement Information
I2Reg. 2 in force at 27.7.2021, see reg. 1(2)
3.—(1) In these Regulations—
“Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5th 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(1);
[F3“Regulation (EU) 2017/746” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU;]
“ethics committee” means a research ethics committee recognised or established by, or on behalf of, the Scottish Ministers, the Welsh Ministers, the Department of Health in Northern Ireland or the Health Research Authority(2).
[F4“Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators;]
[F4“UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020.]
[F5(2) Unless otherwise defined in these Regulations—
(a)terms used in Parts 2 and 3 have the same meaning as in Regulation (EU) 2017/745;
(b)terms used in Parts 2A and 3A have the same meaning as in Regulation (EU) 2017/746.]
[F6(3) In these Regulations, a reference to an Article or an Annex is—
(a)in Parts 2 and 3, a reference to an Article or an Annex of Regulation (EU) 2017/745;
(b)in Parts 2A and 3A, a reference to an Article or an Annex of Regulation (EU) 2017/746.]
Textual Amendments
F3Words in reg. 3(1) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(a)(i)
F4Words in reg. 3(1) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(a)(ii)
F5Reg. 3(2) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(b)
F6Reg. 3(3) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(c)
Commencement Information
I3Reg. 3 in force at 27.7.2021, see reg. 1(2)
4. In these Regulations—
(a)Parts 4, 5 and 6 apply to all devices to which Regulation (EU) 2017/745 and Regulation (EU) 2017/746 apply;
(b)Parts 2 and 3 apply to all devices to which Regulation (EU) 2017/745 applies;
(c)Parts 2A and 3A apply to all devices to which Regulation (EU) 2017/746 applies.]
Textual Amendments
F7Reg. 4 substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 30
Commencement Information
I4Reg. 4 in force at 27.7.2021, see reg. 1(2)
OJ No. L 117, 05.05.2017, p. 1., amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020, OJ No. L 130, 24.04.2020, p.18.
The Health Research Authority is established by section 109 of the Care Act 2014 (c.23).