MedTech Europe: ‘Pause The EU MDR And IVDR Now!’
For the first time, the EU medtech industry has called on the European institutions to postpone implementation of the Medical Device Regulation and the IVD Regulation until the COVID-19 crisis is over.
You may also be interested in...
At last there is news from the Commission that it is responding to the growing pressure to delay the implementation of the EU Medical Device Regulation. It looks like there will be a one-year reprieve. But uncertainty remains.
The slow designation of notified bodies under the IVD Regulation is likely to mean that the IVD industry will face hurdles due to lack of timely availability of these resources when demand rises exponentially.
The European Commission has reiterated that the MDR deadline of 26 May will go ahead despite the COVID-19 crisis, further hampering notified body resources and audit freedoms. It has put its foot on the accelerator by issuing seven new documents.