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?
The hope is now that a new EU document will be issued to address head on the scale of bottlenecks at notified bodies and of products needing to be removed from the market.
With a sense of desperation building among stakeholders over the challenges in ensuring all products are compliant with the Medical Device Regulation in time, high-level solutions are being considered. But a further MDR delay is not an option.