Regulation 29 Amendment to regulation 3 (interpretation)

In regulation 3—

(a)

in paragraph (1)—

(i)

after the definition of “Regulation (EU) 2017/745” insert—

““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;”

(ii)

after the definition of “ethics committee” insert—

““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^f1.”;

(b)

for paragraph (2) substitute—

“(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.”;

(c)

for paragraph (3) substitute—

“(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.”.

Annotations

Footnotes

f1: S.I. 2020/1460.