This guidance provides elements useful for the qualification of the groups of products without an intended medical purpose listed in Annex XVI of the MDR (hereinafter referred to as devices). It also explains and provides examples for the application of certain classification rules to devices. This guidance should be read in conjunction with the MDCG 2021-24 on the classification of medical devices.

If you are interested in the qualification and classification of Annex XVI products, please consult the reference.



MDCG 2023-5 - Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies

MDCG 2021-24 - Guidance on classification of medical devices