EU Commission proposal on extension of MDR transition periods
06 January 2023
As we reported in December, the EU’s Health Commissioner proposed an extension of the transition periods under the EU MDR in order to address the potential for shortages in the supply of medical devices.
The proposal has now been adopted by the EU Commission, and the official text of the amendment is now available. The proposed changes to the transition period have been confirmed as:
· 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.
· 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.
· Removal of 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end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn.
These changes have yet to take effect and still require the approval of the EU Parliament and Council.
