The Medical Device Coordination Group #MDCG has published “MDCG 2021-28 Substantial Modification of Clinical Investigation under Medical Device Regulation”.

 The document provides a link to a template to help identify clearly which documents are relevant to the modification.

 🔗 Original Document :  https://ec.europa.eu/health/system/files/2022-01/mdcg_2021-28_en.pdf

🔗 Template :  https://ec.europa.eu/health/system/files/2021-12/mdcg_2021-28_annex_1_en.pdf