Annex XVI Product: Official Q&A Released

Regulation (EU) on Medical Devices (MDR) now includes products without a specific medical purpose listed in its Annex XVI. Common specifications for risk management of these products have been outlined in Commission Implementing Regulation (EU) 2022/2346 (CS), effective from June 22, 2023. Regulation (EU) 2023/607 extended transitional provisions under MDR from March 20, 2023, introducing conditions for their application. To align transitional provisions in CS with the amended MDR, Commission Implementing Regulation (EU) 2023/1194 was introduced.

The new Q&A document conforms to the requirements of both the amended MDR and CS and is available at the following link:

https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf