MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products

The Medical Device Coordination Group (MDCG) has published the MDCG 2023-6 guidance that is applicable to products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745 (MDR) and covered by the Commission Implementing Regulation (EU) 2022/2346.

This guidance covers the demonstration of equivalence, based on data pertaining to an already existing device, for the purpose of CE-marking under MDR.

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

DOWNLOAD THE GUIDANCE MDCG 2023-6