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.
This page organises key MDCG and other official guidance by device class and type, making it easier to find the guidance most relevant to a specific product.
MEDDEV and NB-MED documents were produced under the old MDD/AIMDD/IVDD framework (pre-2017). While some retain value as interpretive background, they must be read critically in the context of MDR/IVDR requirements. MDR/IVDR supersede these older documents where inconsistent. For current compliance questions, always refer to MDCG guidance first, then to MEDDEV only where MDCG provides no explicit guidance.