Just over four years after it was published in the Official Journal, Regulation (EU) 2017/745 (the EU MDR) becomes applicable on 26 May 2021. With just over a month to go, we look ahead to recent developments in the sector and provide some thoughts on the problems the impending application date is causing.
Throughout the period between entry into force and actual application of the EU MDR, the Commission has kept the industry updated of implementing measures through its Rolling Plan. A quick look through the updated copy of this document uploaded last week reveals, with just over a month to go, still only 4/10 of implementing acts have been completed and many of the other actions and initiatives listed are still pending. This is perhaps unsurprising given the concerns repeatedly voiced by industry bodies that the infrastructure for the new medical devices regulatory framework simply does not exist.
The number of EU MDR designated Notified Bodies continues to grow with more likely to be appointed over the coming months. The remaining outstanding items for the Commission to address include small matters such as EUDAMED; the establishment of common specifications for devices (including devices without medical purposes) and high-risk in vitro diagnostics; and EU reference laboratories (EURLs) for in vitro diagnostics. The timelines for these have all been pushed back to the end of this year or the beginning of 2022.
The implementation era of the EU MDR is almost over but it is still causing headaches. As emphasised in previous articles, the planning required to comply with the new regime is complex and pervasive. Many will find themselves backed into an unpleasant corner and from 26 May 2021 may be facing a period of temporary “non-compliance”.
The EU MDR does contain some transitional provisions for certain types of devices that kick in from the end of May. These transitional provisions allow for extended “placing on the market” and “putting in to service” of certain legacy medical devices but are limited in scope.
This update wouldn’t be complete without a mention for the EU MDR’s sister, Regulation EU 2017/746 on in-vitro diagnostic medical devices (the IVDR). The IVDR becomes applicable on 26 May 2022, but despite the extra year many face the same difficult situation with regards this set of requirements.
The jump in the requirements for in-vitro devices brought about by the IVDR is considerably greater than the jump for general medical devices brought by the MDR and companies who are only now thinking about how to comply with the IVDR regime are probably too late to meet all the requirements in time.