New MDCG Guidance for MDR Annex XVI products!
On 14 December 2023, two new MDCG Guidance for groups of products without an intended medical purpose that are listed in Annex XVI of the (EU) 2017/745 Medical Device Regulation (MDR) were published on the EU Commission's website:
- MDCG 2023-5 Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies
- MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies
MDCG 2023-5 Guidance; provides information on how to qualify a product as a product without an intended medical purpose listed in Annex XVI of the MDR, and also provides explanations and examples of the application of certain classification rules to products without an intended medical purpose.
MDCG 2023-6 Guidance; covers the explanations regarding the demonstration of equivalence, based on data on an already existing device, for the purpose of CE marking under the MDR of products without an intended medical purpose listed in Annex XVI of the MDR and covered by the Common Specifications*. This guidance document should be used in conjunction with the MDCG 2020-5 guidance on equivalence.
*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
You can access the relevant MDCG guides using the links below.
https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf
https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf