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