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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. It is not legally binding but is followed by notified bodies and competent authorities and departing from it requires justification.

Guidance — by device class & type

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.