Latest Numbers Show How MDR And IVDR Certificates Are Growing As Applications Mount

 
• By Amanda Maxwell

Notified bodies have long been under huge pressure to perform more conformity assessments under the Medical Device and IVD Regulations than their resources allowed. Now timelines are more relaxed, a realistic oversight of numbers and understanding of trends is critical to their planning.

Bottleneck
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The European Commission has published a survey showing the number of certificates granted by and applications made to EU notified bodies designated under the MDR and IVDR. The figures represent a snapshot until 31 March 2023.

The aim of the survey is to monitor and analyze the availability of medical devices on the EU market under the MDR and the

The results feature a disclaimer that some data may still need

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