On January 6th, 2023, the European Commission (EC) adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the MDR (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 (i.e., no ‘sell-off’ date).
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
This proposal does not change any of the current safety and performance requirements provided for in the MDR. It only amends the transitional provisions to give more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation. The length of the proposed extension of the transition periods depends on the type of device: higher risk devices (Class III and Class IIb implantable) such as pacemakers and hip implants will benefit from a shorter transition period (until December 31st 2027) than medium and lower risk ones (Class IIa, Class Im, Is and Ir), such as syringes or reusable surgical instruments (until December 31st 2028).
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 Class III and Iib implantable devices and until 31 December 2028 for Class Iib non-implantable, Class Iia and all Class I (m-s-r) 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 MDR will benefit from the additional time.
- The proposal introduces a transition period until 26 May 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 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 MDR 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 European 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 European market remain available to healthcare systems and to patients in need.
Please note that this proposal still needs to be adopted by the European Parliament and the Council of the European Union through an accelerated co-decision procedure. In the unlikely event anything would change we will communicate this to you!
What does this mean to you?
This amending regulation aims to ensure the availability of safe medical devices for European patients. This 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 of the Regulation. It is still highly advisable for all manufacturers to prepare for certification under the MDR as soon as possible and not wait until the end of the transition period. For IVD manufacturers the only thing that changes is the removal of the sell-off date (27 May 2025) mentioned in Article 110 (4). Depending on the shelf-life of the devices involved, this may buy to IVD manufacturers some extra time to get the Notified Body approval for their IVDR devices.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.