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 the COVID-19 outbreak and the associated public health crisis presented an unprecedented challenge to EU member states and constituted an immense burden for national authorities, health institutions, Union citizens and economic operators. Further, it recognised that the public health crisis created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of the MDR.
The Regulation effectively provided considerable regulatory easement for the medical device industry, Notified Bodies and EU regulators, and with a view to allow more directed action against the pandemic.
This publication addresses what will change under MDR, the impact of Brexit and the practical impact of this move.