Consultants Over Notified Bodies? Manufacturers Losing Vital Resources With High Demand For EU Regulatory Experts
Executive Summary
NSF Ireland recently withdrew its application for notified body status under the IVDR and MDR. Its reason? Demand among manufacturers for consultancy outweighs the need for another notified body. But aren't more notified body resources needed too?
You may also be interested in...
IVDR Notified Body Pulls Applications As The EU System Struggles To Cope
European Commission figures have already suggested IVD testing capacity could be woefully short of demand. Now one notified body applicant is dropping out. What are the implications?
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.