EU MDR News! (Product Without an Intended Medical Purpose (Annex XVI))
Today (14/12) the Medical Device Coordination Group (MDCG) has published two new documents regarding Product Without an Intended Medical Purpose (Annex XVI).
“MDCG 2023-5 Guidance on qualification and classification of Annex XVI products”. This guidance document provides elements useful for the qualification of a product as a product without an intended medical purpose listed in Annex XVI to the MDR. It also provides explanations and examples for the application of certain classification rules to products without an intended medical purpose.
“MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products”. 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. 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.
Link MDCG 2023-5: https://lnkd.in/erGBPNf2
Link MDCG 2023-6: https://lnkd.in/eQ8NUFDY