The Medical Device Coordination Group #MDCG has published a new document, “Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)” on January 27 2022.

 The 32 page document covers many aspects related to IVD clinical evidence, defining the “approach by which collection, generation and documentation of supporting data for an IVD may be conducted prior to the placing on the market or putting into service”

 🔗 Original Document :  https://ec.europa.eu/health/system/files/2022-01/mdcg_2022-2_en.pdf