2023-12

On December 14 2 new guidances were published by the MDCG:

– MDCG 2023-5: Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies
Products without an intended medical purpose that are listed in the Annex XVI to MDR and that are included in the scope sections of the CS’ annexes are covered also by the MDR. Qualification of a product without an intended medial purpose precedes its classification. Only products that qualify as devices and that are covered by the CS and the MDR should then be classified according to the rules set out in Annex VIII to MDR and in Commission Implementing
Regulation (EU) 2022/2347 on reclassification. Classification rules set out in Annex VIII to MDR apply to those products. Also Commission Implementing Regulation (EU) 2022/2347 applies for classification purposes of certain active devices without an intended medical purpose.

– MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies.
According to Commission Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices5, hereinafter referred to as CS, in general it is not possible to demonstrate equivalence between a medical device and a product without an intended medical purpose where all available results of clinical investigations relate to medical devices only. Therefore, clinical investigations should be performed for products without an intended medical
purpose.

Both guidances can be downloaded in our library (see above links)

Source: European Commission