Can A Device Remain On EU Market When Its Notified Body Ceases To Operate?
EU regulatory authorities are starting to take action to prevent hundreds of products from being unnecessarily withdrawn from the EU market following the exit of notified bodies from the medtech sector. But will this practical solution mean some CE-marked products will be floating freely around Europe with no notified body backstop?
You may also be interested in...
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.
While the EU has selected the CND system as the basis for its nomenclature, GMDN is becoming increasingly valued on the US and international scene. How does it see its latest role panning out globally?