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)
(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—
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;
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.
F7Scope4.
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.