Commission adopts proposal allowing more time to certify medical devices to mitigate risks of shortages

On 6 January 2023,  the European Commission adopted a proposal allowing 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 Medical Devices Regulation.
  • does not change any of the current safety and performance requirements provided for in the Medical Devices Regulation
  • amends the transitional provisions to give more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation.
  • 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).

Further details are provided below.

What does the length of the proposed extension period depend on?

The length of the proposed extension of the transition periods depends on the type of device: higher risk devices such as pacemakers and hip implants will benefit from a shorter transition period (until December 2027) than medium and lower risk ones, such as syringes or reusable surgical instruments (until December 2028).

Put simply, the new deadlines depend on the risk class of the medical device and will ensure continued access to medical devices for patients.

What are the key elements of the proposal?

1. Medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021

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 as per the table below:

Device typeExtension of the transition period to the new rules
Higher risk devicesExtended from 26 May 2024 to 31 December 2027
Medium and lower risk devices.Extended until 31 December 2028

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.

2. Class III implantable custom-made devices

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.

3. Validity of Certificates

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.

4. ‘sell-off’ date currently established in the MDR and IVDR

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.

What are the next steps?

The proposal now needs to be adopted by the European Parliament and the Council through an accelerated co-decision procedure.

Is there a Q&A document available?

Yes there is and you can view it here.

Source: eceuropa.eu