PART 1

Preliminary

Citation and commencement
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.

Extent and application
2
1
Parts 1, 4, 5, 7 and 8 extend to England and Wales, Scotland and Northern Ireland.
2
Parts 2, 2A, 3 , 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.

Interpretation
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 ;
- “
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 .
- “
Institute
” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators;
- “
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.
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
.
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
.

Scope
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.
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).
Reg. 1 in force at 27.7.2021, see reg. 1(2)
Reg. 2 in force at 27.7.2021, see reg. 1(2)
Reg. 3 in force at 27.7.2021, see reg. 1(2)
Reg. 4 in force at 27.7.2021, see reg. 1(2)
Word 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)
Word 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)
Words 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)
Words 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)
Reg. 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)
Reg. 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)
Reg. 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