Commission Calls For Notified Body Applicants As It Recognizes EU IVD Industry In Some Trouble

The European Commission is publicly recognizing the huge hurdles ahead for the IVD industry in complying with the IVD Regulation. Delaying the regulation has long been off its agenda, but it is struggling to find solutions.

Megaphone cry. Credit: dangdumrong/Shutterstock.com

European Commission devices expert, Erik Hansson, made a direct plea at the RAPS Euro Convergence meeting for more organizations to apply for IVD Regulation notified body status.

His appeal left few in doubt that the IVD industry is going to be severely challenged to find enough capacity...

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