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IVDR Notified Body Pulls Applications As The EU System Struggles To Cope

 
• By Amanda Maxwell

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?

PCR strip test tubes and micropipette in genetics laboratory. Toned photo

The IVD sector fears increased pressure under the new IVD Regulation following the news that NSF Certification Ireland has withdrawn its notified body designation application for the European IVD Regulation (as well as for the Medical Device Regulation, where it was applying with a very much reduced scope).

Industry is particularly concerned that the move will lead to more pressure in accessing notified body capacity given that the demand on notified bodies, whose numbers are shrinking fast, is...

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