The MDCG (Medical Devices Coordination Group) published the guidance MDCG 2022-15 on the appropriate surveillance to be conducted by Notified Bodies for in vitro diagnostic medical devices covered by certificates issued under Directive 98/79/EC. This document:
- Clarifies elements to be verified by Notified Bodies and,
- Allows manufacturers placing on the market devices covered by the above-mentioned certificates (legacy devices) since May 26, 2022, to identify the topics that will be evaluated during surveillance audits.
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