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EU Medtech Ecosystem Will Suffer Unless Notified Body Workload Concerns Are Addressed – The German View

Executive Summary

An EU notified body redesignation rate of 10 per year is too slow. It won't help small companies using the new Medical Device and IVD Regulation systems, and is leaving NBs feeling let down and with a mountain to climb. A German industry group weighs in on the need to speed up redesignations.

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