Commission's Draft EU Standardization Request May Overwhelm Tech Committees At 11th Hour
A great many EU medtech standards may not be ready in time for manufacturers to demonstrate compliance with the new regulations when they apply in 2020 and 2022. So, what is happening?
You may also be interested in...
It is now just over a year before the full application of the new EU Medical Devices Regulation. But there are delays in the standards that underpin it. Will any be referenced in time? What can the Commission do to speed up the process?
With just under 120 days until the full application of the EU’s Medical Device Regulation, and fears growing of the loss of products seen as non-compliant, the EU medtech industry has identified a way of broadening the application of the “grace period.” It is a legal way of addressing the potential loss of tens of thousands of products come 26 May, says MedTech Europe’s Oliver Bisazza.
February sees some vitally important issues on the European Commission’s agenda, including areas where the medtech sector has been clamoring for progress in terms of clarity over the Commission's thinking and guidance documents. This year's meetings are plentiful and critical.