29. 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(1).”;
(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.”.