On December 14th, 2023, the Medical Device Coordination Group (MDCG) released 2 new guidance documents for products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR). A guidance on qualification and classification of Annex XVI products (MDCG 2023-05) and a guidance on demonstration of equivalence for Annex XVI products (MDCG 2023-06). Both are intended for medical device manufacturers and notified bodies.
MDCG 2023-05: A 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.
For Annex XVI products the MDR does not provide any definition. Therefore, to determine if a product is covered by the MDR, the descriptions of the groups of products listed in the Annex XVI must be used. This guidance clarifies that the definitions of “medical device” and “accessory for a medical device” should not be used for Annex XVI products.
MDCG 2023-06: A 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 and covered by the common specifications.
It gives guidance to demonstrate equivalence for the following cases
- Product without an intended medical purpose vs product without an intended medical purpose
- Product without an intended medical purpose vs analogous medical device
- Product without an intended medical purpose vs dual-purpose device
What does this mean to you?
MDCG 2023-05 and MDCG 2023-06 are of importance for all medical device manufacturers of products without an intended medical purpose as listed in Annex XVI of MDR.
