MDCG 2021-10 – Status of Appendixes E-I of IMDRF N48 under EU Regulatory Framework ✅

Written By MDRG
2021-07-23 - MDCG 21-10.png

The #MDCG has endorsed the principles of the #IMDRF N48 guidance document (Appendixes E-I), and use this new document to provide clarifications as to how certain principles and examples apply under the MDR/IVDR.

 A simple table is provided to outline the principles and their application to MDR and IVDR separately.

 🔗 https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-10_en.pdf

MDRG
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