January 6, 2023
By Annette van Raamsdonk
As we have reported in recent months, the European Commission (EC) proposed that the Medical Devices Regulation MDR (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746 transitional provisions need to be amended in order to avoid discontinuation of healthcare in the EU. The EC seems to be working hard on adopting the amendment and has published a factsheet giving a high-level overview of the reasons behind their efforts, as well as related long- and short-term actions.
The amendment aims at introducing a staggered extension of the transition period provided for in the MDR, under certain conditions. It also aims to delete the “sell-off” deadline in both the MDR and IVDR; as the Regulations currently stand, devices placed on the EU market and still in the supply chain but not yet put into service would have to be withdrawn after the sell-off deadline passes.
Short-term actions addressed by the amendment
- Staggered and conditional extension of the transition period until 2027/2028, according to the risk class of the device
- Extended validity of CE certificates
- Cancellation of “sell-off” date, i.e., allowing devices placed on the market before or during the transition period to continue to be made available without time limitation
Short-term actions addressed in MDCG documents
- Bridging measures based on the application of market surveillance provisions (Article 97 MDR, MDCG 2022-18)
- Gaining momentum to increase the number of Notified Bodies (NBs)
- Implementation of actions to enhance NB capacity and ensure the availability of medical devices and IVDs (MDCG 2022-14)
- Pilot project on scientific advice for clinical development strategies for high-risk devices
- Targeted support for small and medium-sized enterprises (SMEs) through the Enterprise Europe Network (including financial support via the EU4Health Program)
- Tailored solutions for orphan devices (devices crucial for treating a relatively small group of patients, especially children)
We will keep you posted on when the proposed amendment will be adopted. In the event that your NB-issued certificate(s) expires prior to the adoption of the amendment, please note Article 97 MDR might be an option for you to keep marketing in the EU.
Annette van Raamsdonk is Lead Quality & Regulatory Affairs Consultant at Emergo by UL in The Netherlands.
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