The MDCG has released a guidance entitled MDCG 2023-5: Guidance on qualification and classification of Annex XVI products. This guidance is one of two new guidance’s issued by the MDCG regarding Annex XVI products during the month of December.
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.
The guidance document can be used by manufacturers to help them determine if their device is an Annex XVI product and help them classify the device using the classification rules of the MDR. We urge all manufacturers of Annex XVI devices to use this guidance document as it is an excellent tool. We would also like to stress that this document should be used in conjunction with the MDR.
The guidance document can be accessed using the following link
