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?
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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?
Eighteen years of free trade threatens to come to a sudden stop, as a result of the stalemate in the market access agreement between Switzerland and the EU. Industry association Swiss Medtech is advising local medtech manufacturers to find notified bodies and authorized representatives based in the EU. However, local company SQS remains confident of its ongoing notified body role.
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.