# The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023, 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.”;
(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.”.

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Source: https://www.legislation.gov.uk/ukdsi/2023/9780348253696/regulation/29 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023/regulation-29
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

