PART 1Preliminary
Citation and commencement1
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 application2
1
Parts 1, 4, 5, 7 and 8 extend to England and Wales, Scotland and Northern Ireland.
2
Parts 2, 3 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.
Interpretation3
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/EEC3;
“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 Authority4.
2
Unless otherwise defined in these Regulations, terms used have the same meaning as in Regulation (EU) 2017/745.
3
In these Regulations a reference to—
a
an Article is a reference to an Article of Regulation (EU) 2017/745;
b
an Annex is a reference to an Annex to Regulation (EU) 2017/745.
Scope4
These Regulations apply to all devices to which Regulation (EU) 2017/745 applies.