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?
You may also be interested in...
Consultants Over Notified Bodies? Manufacturers Losing Vital Resources With High Demand For EU Regulatory Experts
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?
New designations of notified bodies under the Medical Device Regulation continue to trickle through slowly. The latest brings the EU’s total to 33, still way short of the previous 80 or so under the Medical Devices Directive.
Changes have occurred in the management focus within the European Commission’s directorate responsible for medtech but not within the devices leadership; familiar faces remain.