MDCG (Medical Device Coordination Group) guidance documents are official EU publications that support the practical interpretation of the MDR/IVDR. They are not legally binding, but they represent a key technical reference for manufacturers, notified bodies and other economic operators.
They clarify critical aspects such as classification, UDI, clinical evaluation, PMS/PMCF and technical documentation, providing harmonised criteria applied across the European Union.
Following MDCG guidance helps reduce ambiguity, prevent non-compliance and ensure a consistent application of regulatory requirements.
[…]
They clarify critical aspects such as classification, UDI, clinical evaluation, PMS/PMCF and technical documentation, providing harmonised criteria applied across the European Union.
Following MDCG guidance helps reduce ambiguity, prevent non-compliance and ensure a consistent application of regulatory requirements.
[…]