Guidance MDCG 2022-15 on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD

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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