Guidance from the EU Commission/MDCG
The Medical Device Coordination Group (MDCG) comprises participants from EU member states and the EU Commission. MDCG creates guidance for the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR).
The guidance is not legally binding but serves as a valuable resource for market participants. Its purpose is to ensure an efficient and harmonized understanding of the regulations.
The EU Commission has prepared fact sheets for various market participants.