EU Coordinates Market Surveillance For The First Time: Pilot Being Launched
‘JAMS’ has been strengthening the European market surveillance network and helping lower-resourced member states develop skills and capacity. Coordinated pilot project work is next.
You may also be interested in...
The EU must keep its medtech regulation under review as rapidly changing technology and external market factors may be challenging the operability of some aspects of the new medtech regulations, especially for less mature businesses and SMEs. Legal medtech expert, Shuna Mason, of CMS explains why.
Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.
The highest risk IVDs are due to receive an extra layer of regulatory scrutiny in the EU. But it is taking a long time to set up the structures needed.