Medical Device Regulatory Guide

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MDR Annex XVI Common Specification Draft Published 📚

The #EC has published a draft version of the Annex XVI Common Specification (in English).  Note that this is not the final, complete file as it is missing specifications for each category of Annex XVI.

 Important information includes:

-          Information related to the timeline

-          Annexes for each category (but little/no information)

-          Update to risk management planning

🔗 Original Document :  https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=PI_COM:Ares(2022)271416&from=EN