The eagerly anticipated proposal to postpone the MDR has been released.

The high-level EU Commission press release is available: HERE

The Commission’s 15-page proposal is available: HERE

Background

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 Proposal

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.

Which products are eligible?

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.

Extension of the Transition Period

The proposed new dates are:

• • 31 December 2027- Class IIb implantable and Class III devices*
  • 31 December 2028 – Class IIb (all other), Class IIa, Class I sterile/measuring and Class I self-certified devices

*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

Conditions

Outlined in the proposal, but already in the current version of Article 120(3) of the MDR:

• • Products must continue to comply with the MDD/AIMDD, as applicable.
  • Devices do not undergo significant changes in the design and intended purpose.
  • Devices must comply with MDR requirements related to post-market surveillance, market-surveillance, vigilance, and registration of economic operators and devices.

New conditions outlined in the proposal:

• • Device must not present an “unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health”. (Refer to MDR Articles 94 & 95 for the concept of “unacceptable risk”)
    • No systematic check of the device’s safety is required, as devices with Notified Body issued CE Marking certificates are already under “appropriate surveillance” by the Notified Body.
    • If, at any time, a Competent Authority finds that the device presents an unacceptable risk, the transition period ceases to apply for the device.
  • No later than 26 May 2024:
    • Manufacturer must put in place a Quality Management System (QMS) in accordance with Article 10(9) of the MDR.
      • No specific attestation, i.e., no self-declaration or verification is required to confirm this has occurred.
    • Manufacturer must have lodged an application with a Notified Body for the legacy device(s).
  • No later than 26 September 2024:
    • The manufacturer and Notified Body must have signed a written agreement.
      • This is to help ensure that only devices that will be transitioned to MDR CE Marking will benefit, i.e., if you do not intend to MDR CE Mark a particular device, then it is not eligible for the extended transition period as it has not met the conditions.
      • However, if that legacy device is not being transitioned to the MDR because it is being replaced by a ‘new generation’ device, then it is eligible for the extended transition period if an application has been lodged for the new device.
    • Custom-made Class III implantable devices will also now be eligible for a transition period until 26 May 2026.
      • These devices should have complied with the MDR by 26 May 2021. Therefore, if they are still undergoing the MDR conformity assessment process, they have been off the market since then.
      • Same conditions apply: they must have lodged an application with a Notified Body by 26 May 2024 and have a signed agreement in place by 26 September 2024.

Removal of the Sell-off Date

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.

What if my MDD/AIMDD CE Certificate expires before the new legislative amendment goes into force?

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

What next?

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.