All MDCG guidance — listed by topic
MDCG guidance is published by the Medical Device Coordination Group and represents the authoritative interpretation of MDR/IVDR requirements by the European Commission and member states. While not legally binding, it is widely followed by notified bodies and national competent authorities (NCAs). Departing from MDCG guidance positions requires robust technical or scientific justification and may be subject to challenge during NB assessment or NCA inspection.