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EU Notified Body Figures Demonstrate The Scale And Timing Of Capacity Shortfall

 
• By Amanda Maxwell

Companies have been warned if they delay in applying for certification under the new Medical Device and IVD Regulations their products may not be reviewed in time. And the scale of the potential bottleneck is alarming.  

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Latest figures from the EU association of medtech notified bodies, TEAM-NB, highlight how important it is for medical device and IVD companies to not delay in applying to renew their notified body certificates for legacy products in the context of the Medical Device and IVD Regulations.

If the renewal is left until closer to the May 2024 deadline for devices under the MDR, for example, there...

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