On September 26th, 2023, the Medical Device Coordination Group (MDCG) released a Q&A on the transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR. The newly published Q&A document intends to facilitate the application of the transitional provisions set out in Commission Implementing Regulation (EU) 2022/2346 which sets out the Common specifications addressing the application of risk management to Annex XVI products, as amended by Commission Implementing Regulation (EU) 2023/1194 which addresses the transitional provisions for these Annex XVI products.
Regulation (EU) 2017/745 on medical devices (MDR) and the Common Specifications (CS) are applicable to Annex XVI products as from June 22nd 2023.
This Q&A document clarifies the transitional provisions and conditions to be taken into account for Annex XVI products:
- Products for which a notified body is involved in the conformity assessment and the manufacturer decides to carry out a clinical investigation.
- Products for which a notified body is involved in the conformity assessment and the manufacturer does not intend to perform a clinical investigation.
- Products covered by an MDD certificate as per MDR.
- Products covered by an MDD certificate as per the CS.
- Products incorporating a medicinal product
- For a dual-purpose device
It further clarifies how manufacturers can demonstrate that their product benefits from the transitional period and that there is no deadline to make available products placed on market during the transitional period. Last, it conforms that notified bodies can issue certificates fir Annex XVI products under the MDR during the transitional provisions.
What does this mean to you?
This Q&A document is of relevance for MD manufacturers of products without an intended purpose covered under Annex XVI of the MDR.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.