MCDG publishes guidance documents for products listed in Annex XVI to MDR

Article summary

The Medical Device Coordination Group (MDCG) has published guidance documents on qualification and classification, and on demonstration of equivalence for products set out in Annex XVI to Regulation 2017/745 (the Medical Devices Regulation (MDR)). The guidance on qualification and classification outlines the elements useful for the qualification of a product as a product without an intended medical purpose listed in Annex XVI to the MDR and provides explanations and examples for the application of certain classification rules to products without an intended medical purpose. The second guidance covers 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 to the MDR and covered by Commission Implementing Regulation (EU) 2022/2346 on common specifications for the groups of products without an intended medical purpose listed in Annex XVI to the MDR.