MDCG 2023-6 – Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies –

This MDCG guidance covers the demonstration of equivalence, based on data pertaining to an already existing device, for the purpose of CE-marking under the MDR and is applicable to products without an intended medical purpose listed in the Annex XVI of MDR and covered by the CS.

For dual-purpose devices, which are devices with a medical and a non-medical intended purpose, this guidance applies only to the non-medical intended purpose.

This guidance document should be used in conjunction with MDCG 2020-5 on equivalence

MDCG 2023-6 – Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies – December 2023