Because of the Covid-19 sanitary emergency, the European Commission proposed to delay the application date of the MDR (UE) 2017/745 by one year, cancelling the expected date of May 26, 2020 and postponing it to May 26, 2021.
The UE spokesman Stefan de Keersmaecker declared the Commission is working hard to submit this proposal at the beginning of April, asking to the European Parliament and European Council to approve it quickly before the end of the month.
In the published online declaration, the European Commission explains that the request is aimed to relieve pressure on Competent Authorities, Notified Bodies, manufacturers and the other operators to let them focus on the urgent priorities related to the Coronavirus crisis.
For further confirmation of the need to delay, six members of the European Parliament wrote a letter to the President of the European Commission Ursula von der Leyen and to the Commissioner Stella Kyriakides to explain that low resource are now available to grant the MDR actuation. They propose to keep the current regulatory system and to postpone the date of implementation of the MDR to concentrate on the Covid-19 emergency.
It is not clear what “postponing the application date of the MDR by one year” means yet. Perhaps all expected dates move forward for one year, or just the application date is delayed with no changes of other deadlines.
Only in case of acceptance of the new proposal by the European Parliament and the European Council, new details and procedures will be defined.
At the moment the in-vitro diagnostic medical device field is not involved by the European Commission proposal: the expected application date remains May 26, 2022.
Also, it is relevant the U.S.A. petition asking for a 3-year delay for the MDR and IVDR implementation.
In case of denial, the US proposes at least to allow putting into the market the legacy devices until 2024, because they can be considered safe and to let the Notified Bodies give priority to devices requiring a brand new certification.