EU Expert Panels On The Starting Line But Waiting For Commission Whistle
The European Commission and notified bodies are now talking about how the expert panel process will work for high-risk devices.
You may also be interested in...
The appointment of the European Commission expert panels opens the door to full conformity assessment for innovative high-risk devices. But the uneven distribution of experts will mean queues are expected for some type of work.
No one should underestimate the scale of the obstacles companies face trying to comply in time with the IVD Regulation by its 26 May 2022 deadline, especially now data is starting to emerge to highlight the size of the problem.
Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.