28.09.2023 - 12:14   /   5,210

European Commission has published on 26 September 2023 a Question&Answer document which explains the transitional provisions for products without an intended medical purpose covered by Annex XVI of the 2017/745/EU MDR. With this Q&A document, it is intended to facilitate the application of the transitional provisions set out in Commission Implementing Regulation (EU) 2022/2346, as amended by Commission Implementing Regulation (EU) 2023/1194.

You can access the mentioned Q&A document using the link below:

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