The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024
Information
Type
Regulation
Regulated products
IVDMD, Medical Devices
Published
February 22, 2024
Last updated
February 22, 2024
Description
These Regulations make provision for the implementation in respect of Northern Ireland of 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 (“Regulation (EU) 2017/746”). Article 5(4) of the Windsor Framework between the United Kingdom and the European Union (“the Windsor Framework”) provides that the EU law listed in Annex 2 to the Windsor Framework will apply to and in the UK, in respect of Northern Ireland. Regulation (EU) 2017/746 is listed in Annex 2 and applied from 26 May 2022. Section 7A of the European Union (Withdrawal) Act 2018 gives effect to Regulation (EU) 2017/746 in domestic law.
Tags
Organization
Country / Region
United Kingdom
License
Open Government Licence 3.0 (United Kingdom)