The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024

Amendment to regulation 2 (interpretation) in relation to Northern Ireland

This section has no associated Explanatory Memorandum

10.  In regulation 2(1)(1) after the definition of “Regulation (EU) 2017/745” insert—

Regulation (EU) 2017/746” means Regulation (EU) 2017/746(2) 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;

Regulation (EU) 2022/1107” means Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council(3);.

(1)

Amended by S.I. 2021/905; there are other amending instruments but none is relevant.

(2)

OJ No. L 117, 05.05.2017, p.176; amended by OJ No. L 19, 28.01.2022, p.3; OJ No. L 70, 08.03.2023, p.3; and OJ No. L 80, 20.03.2023, p.24.

(3)

OJ No. L 178, 05.07.2022, p.3.