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EC MDR Guidance on New Safety and Clinical Performance Summary

The main purpose of this document is to provide guidance on the presentation,content and validation of the SSCP. The word “shall” is used when there is a corresponding “shall” in the MDR, otherwise “should” or “recommended” etc. is used indicating the interpretation of the MDR.

 

MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies

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