EPF's reaction to the proposed amendments of the Medical Devices Regulation
Following emerging reports of disruptions in the availability of many medical devices in the EU and repeated calls for action by stakeholders, including the European Patients’ forum (EPF), the European Commission published its proposal for a Regulation amending the Medical Devices Regulation (MDR) on Friday 6 January.
EPF is concerned about the emerging and increasing shortages of medical devices attributed to insufficient recertification capacity under the new MDR, and calls on the Commission, industry, and Member States to take urgent and adequate measures to implement the Regulation.
The new Commission’s proposal introduces new deadlines for compliance with the MDR depending on the risk class of the medical devices. Originally, devices on the market had to comply with the MDR by 26 May 2024. Under the proposed amendment, the deadline for high-risk devices to comply with the new rules would be extended to the end of 2027 instead of May 2024, while medium and low-risk devices would have to meet the requirements by the end of 2028.
In addition, the Commission proposes to delete the “sell-off date” currently established in the MDR and the In Vitro Medical Diagnostic Medical Device Regulation (IVDR). The sell-off date is the deadline after which devices that have already been placed on the market, and are still available for purchase, must be withdrawn.
Out of concern for the availability of medical devices and patient safety, we supported a one-year delay in the application of the 2024 recertification deadline in order to comply with the stricter rules of the MDR on safety assessment. We hope that the three-year delay as well as the other deadline changes announced by the Commission last Friday do not indicate a lower level of ambition and readiness for the implementation of the MDR.
We call on the Commission, Member States, and the medical devices industry to make the substantial investments in the infrastructure needed to implement the Regulation with no further delays.