The effect of Brexit on, and changes in, the European Union medical device regulations

Abstract

With the exit of the UK from the European Union and the European Union Regulation 201/745 coming into effect on 26 May 2021, the regulatory landscape for medical devices is undergoing a substantial change, the implications of which will be felt by those procuring and using medical devices in clinical settings. This article outlines the changes that clinicians, as users of medical devices, should be aware of in the immediate future.