EU Guidance Document To Ensure Devices Are Assessed By Appropriately-Trained Reviewers
How do notified bodies ensure that their personnel, and the teams they allocate for conformity assessment of medical devices, have the precise knowledge and expertise needed? A new EU document gives guidance on this.
You may also be interested in...
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?
Updated medtech notified body figures from the European Commission always make headline news. But industry needs to see real appointments now, not a list of tricky-to-understand numbers.
Erik Hansson remains deputy head of devices in a move to the European Commission’s DG Sante from DG Grow. He now answers to a newly appointed devices head who shares a common educational background but whose recent pharmaceutical role may unsettle the devices industry.