January 12, 2023
Manufacturers with medical devices on the European market may get more time to certify those devices under the new Medical Devices Regulation (MDR).
In December, Stella Kyiakides, the European heath commissioner, proposed postponing the MDR transitional deadlines. Last Friday, the European Commission adopted a formal proposal to give manufacturers more time to certify devices on the market in an effort to mitigate the risk of shortages.
The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines depend on the medical devices' risk class and will ensure continued access to medical devices for patients. It will also allow medical devices placed on the market in accordance with the current legal framework and that are still available to remain on the market (no "sell-off" date).
Under the proposal, high risk devices such as pacemakers and hip implants would need to comply with the MDR by December 2027, while medium and low risk medical devices, such as syringes and reusable surgical instruments, would have until December 2028 to comply.
Key elements of the proposal to extend the transition period for the MDR:
The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.
The proposal introduces a transition period until May 26, 2026, also for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before May 26, 2024.
To reflect the transition periods put forward by these amendments, the proposal extends the validity of certificates issued up until May 26, 2021, the day when the Medical Devices Regulation became applicable.
The European Commission also proposes to remove the "sell-off" date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation. The "sell-off" date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need.
Next, the proposal needs to be adopted by the European Parliament and the Council through an accelerated co-decision procedure.
About the Author(s)
You May Also Like