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. It is not legally binding but is followed by notified bodies and competent authorities and departing from it requires justification.
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. While many remain relevant as interpretive guidance, they must be read in the context of MDR/IVDR requirements, which supersede them where inconsistent.