Transition periods for medical devices to comply to new regulations has been extended to 2027 for higher-risk devices and to 2028 for medium and low-risk devices
The European Commission has adopted a proposal to allow companies more time to certify medical devices. The decision is meant to mitigate the risk of shortages in the European healthcare system.
The European Council and Parliament must still adopt the proposal, which will then allow the MDR and IVDR law to be amended, extending the duration of current CE marks. CE marks obtained under the previous directive will remain valid until the end of 2027 for high-risk devices and until the end of 2028 for all other medical devices.
The proposal does not change any of the current safety and performance requirements provided for in the Medical Devices Regulation. It only amends the transitional provisions to give more time for manufacturers to transition from the previously applicable rules to the new requirements.
Key elements of the proposal:
- For medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. 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 also introduces a transition period until 26 May 2026 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 26 May 2024.
- To reflect the transition periods put forward by these amendments, the proposal extends the validity of certificates issued up until 26 May 2021, the day when the Medical Devices Regulation became applicable.
- The 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end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn.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 sell-off 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.
“Medical devices save lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring and treatment of diseases,” said Margaritis Schinas, the Vice-President for Promoting the European Way of Life. “Medical devices range from simple contact lenses and sticking plasters to sophisticated pacemakers and hip replacements. Our proposal for an extension of the transitional periods for the application of the Medical Devices Regulation will address the risk of shortages of medical devices on the EU market. We will not allow any risk of significant disruption in the supply of various medical devices on the market, which would affect healthcare systems and their ability to provide care to European patients.”