The current date by which eligible ‘legacy’ (MDD/AIMDD) CE marked devices may be placed onto the European market is 26 May 2024.
With a serious threat to the availability of medical devices and significant disruption in supply and to healthcare, the EU Council supported a decision to postpone the transition provision within the MDR. The Council announced that a legislative amendment would be issued in early 2023.
More about the background is available: HERE
The full proposal is linked above if you would like to read more about the legal basis for the amendment, stakeholder consultations, impact assessments, and more.
In this article, we will focus on the proposed amendments.
This is applicable to devices that were CE Marked to the MDD/AIMDD on the MDR’s date of application (26 May 2021) and were eligible under Article 120(3) for the transition period: so-called “legacy” devices.
If you have a new product, then unfortunately, this does not apply to your device. Instead, you are required to CE Mark to the MDR in order to market your device in Europe.
The proposed new dates are:
*The following devices are excluded and are eligible for the 31 December 2028 deadline: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors
Outlined in the proposal, but already in the current version of Article 120(3) of the MDR:
New conditions outlined in the proposal:
The MDR currently states that legacy devices may no longer be ‘made available’ on the European market after 26 May 2025. However, this proposal deletes the ‘sell-off’ period.
This means that if the device is already placed on the market and is safe for use (within the device’s expected lifetime/expiration dates), it can continue to be made available for use.
NOTE: this proposal includes a statement to remove the sell-off provision for IVD devices as well, and to amend the IVDR.
Those devices may be eligible if, before the date the Certificate expired, the manufacturer and Notified Body signed a written agreement related to MDR CE Marking (Section 4.3, second subparagraph, Annex VII) for the devices covered by the expiring certificate.
Otherwise, the devices may be eligible if a Competent Authority has already granted a derogation under Article 59(1) or 97(1).
For more information on Article 97(1), please read: MDCG 2022-18 – Guidance for MDD/AIMDD Manufacturers with Expiring Certificates
Now we wait to see if the final amended text matches the proposal above and to hear the expected entry into force date.
As always, Casus will keep you updated as more information is released.