Today, the European Commission has proposed an extension of the transition period to certify medical devices, as laid out in the Medical Devices Regulation, to mitigate the risk of shortages. The deadline for each device depends on its risk class and will ensure that patients have continued access to them. Additionally, the proposal also removes any ‘sell-off’ dates, meaning medical devices currently on the market in accordance with current legal frameworks will remain available for purchase.
The safety and performance requirements of the Medical Devices Regulation remain in place. This proposal simply amends the transitional provisions to give manufacturers more time for transitioning from the old rules to the new requirements of the Regulation. The duration of the transition period depends on the device’s risk class; higher-risk devices have a shorter timeline until December 2027, medium and lower-risk devices until December 2028. The priority has always been ensuring the availability of safe medical devices for European patients.
Key elements of the proposal include:
The transition period for medical devices covered by a certificate or declaration of conformity issued before 26 May 2021 is extended until 31 December 2027 for higher-risk devices and 31 December 2028 for medium and lower-risk devices.
The proposal includes an extension of the transition period until 26 May 2026 for class III implantable custom-made devices, allowing their manufacturers more time to obtain certification by a notified body. To qualify for this additional period, the manufacturer must apply for a conformity assessment of their device before 26 May 2024.
In order to reflect the transition periods specified in these amendments, the proposal extends the validity of certificates issued prior to 26 May 2021, when the Medical Devices Regulation came into effect.
The Commission proposes to remove the ‘sell-off’ date in the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation. This end date would normally require devices already placed on the market to be withdrawn. Removing this will ensure that safe, essential medical devices remain available to healthcare systems and patients who need them.
The next step is for the European Parliament and Council to adopt the proposal through an accelerated co-decision procedure.
