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BioWorld - Saturday, March 21, 2026
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Home » Survey of EU notified bodies shows backlog of device applications still growing
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Survey of EU notified bodies shows backlog of device applications still growing

Nov. 17, 2022
By Mark McCarty
The problem with notified body (NB) capacity in the European Union is well known, but a recent survey of NBs suggests that more than 17,000 certificates for medical devices and active implanted devices issued under the legacy regulation are set to expire by the end of 2024. More troubling might be the fact that the number of standing applications dwarfs the number of completed applications by a ratio of more than four to one, a gap that continues to grow as calendar year 2022 unwinds.
Medical technology Regulatory

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