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BioWorld - Saturday, July 11, 2026
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Home » Team NB sees widening gap between MDR applications, certificates
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Team NB sees widening gap between MDR applications, certificates

May 29, 2024
By Mark McCarty
The European Association for Medical Devices of Notified Bodies has issued its survey of member NBs for 2023, which includes data that suggest a diminishing appetite for inspections under the Medical Device Single Audit Program. However, the more concerning metric is that the gap between applications for new or renewed medical devices and the number of completed applications continues to widen, a gap that stood at nearly 10,000 such applications at the end of calendar year 2023.
Medical technology Regulatory Europe Legislation NICE

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