This 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 Annex XVI of the MDR and covered by the Common Specification (CS). This guidance should be used in conjunction with MDCG 2020-5 on equivalence.

For further details regarding the demonstration of equivalence for products without intended medical purposes, please consult the reference.

 

 

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

MDCG 2020-5 - Clinical Evaluation – Equivalence, A guide for manufacturers and notified bodies