The Medical Device Regulation, COVID-19 and Brexit
Regulation 2020/561 (Regulation) was passed by the EU in April last year to take account of issues raised by the COVID-19 pandemic and to defer the date of application of certain provisions of Regulation 2017/745 (MDR) by one year. The Regulation was published on 24 April 2020 through an EU accelerated procedure, and although the COVID-19 pandemic is still a major issue, the expiry of the one-year deferral is fast approaching.
The Regulation recognised that…