MDCG 2023-5: Guidance on qualification and classification of Annex XVI products

The Medical Device Coordination Group (MDCG) has published the MDCG 2023-5 guidance that provides elements useful for the qualification of a product as a product without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (MDR). It also gives explanations and examples for the application of certain classification rules to these products.

This guidance document should be used in conjunction with the MDCG 2021-24 guidance on classification of medical devices and take into consideration the Commission Implementing Regulation (EU) 2022/2347 on reclassification of groups of certain active products without an intended medical purpose.

DOWNLOAD THE GUIDANCE MDCG 2023-5