In Summary

The EPSCO Council has proposed that the MDR deadline of 26 May 2024, be postponed until 2027 for Class III and IIb devices, and May 2028 for Class IIa and I devices. Conditions will apply.

There were no major objections from other Council members, and the Council will move forward with an amendment early next year to push out the MDR deadline.

A great win for industry.

Full Story

Today the ESPCO (Employment, Social Policy, Health and Consumer Affairs) Council met to discuss the potential postponement of the MDR.

The topic overview for the meeting can be found: HERE

The recording of the session can be found: HERE

The current MDR compliance deadline for all legacy devices is 26 May 2024. After this date, devices CE Marked to the MDD or AIMDD may no longer be legally placed on the market in Europe.

As noted in the “State of Play” portion of the ESPCO’s topic overview:

• • Notified Bodies have received 8,120 MDR applications from manufacturers
  • Notified Bodies have issued 1,990 certificates under the MDR
  • Notified Bodies estimate issuing 7,000 MDR CE certificates by May 2024

Compare this against the 22,973 certificates currently valid under the MDD and AIMDD, all of which will expire by 26 May 2024, and we all see the problem.

That number does not even factor in the many devices which were Class I self-certified under the MDD, and now require Notified Body CE marking under the MDR. This includes Class I reusable surgical instruments, many software devices, and substance-based products. Without a Notified Body issued CE Marking certificate, these are also all theoretically off the market 27 May 2024.

And let us not forget about non-medical devices which now require a Notified Body CE Marking certificate under Annex XVI of the MDR, such as dermal fillers and lasers for aesthetic use. These products are also competing for Notified Body attention.

There is plenty of finger-pointing: industry isn’t moving fast enough; notified bodies aren’t accepting enough clients, especially SMEs; Competent Authorities are not moving fast enough to designate more Notified Bodies.

Wherever anyone chooses to place blame, the end result is that the patient will feel the final impact of the lack of devices on the market.

Not to mention, the adage used to be “Europe first” because its regulations allowed for innovative products to access the market. But this is no longer the case – very few companies are taking a “Europe first” approach to their product launch schedule.

What is Europe going to do about this?

Postponement Recommendation

The EPSCO Council proposes the following:

• • Extension to the MDR Article 120(3) transitional provision, with staggering deadlines, such as:
    • Class III and IIb devices – May 2027
    • Class IIa and I devices – May 2028
  • Extension of validity of MDD/AIMDD CE Marking certificates for this period, requiring an amendment to Article 120(2) of the MDR
  • Conditions to ensure that the extended transition period is only granted to products that do not present any unacceptable risk to public health and safety, have not undergone significant changes in design or intended purpose and for manufacturers that undertaken steps to comply with the MDR, e.g., have lodged an MDR application with a Notified Body by 26 May 2024
  • Removal of the ‘sell off’ provision under Article 120(4) for the MDR and 110(4) of the IVDR, to prevent safe devices already on the market from being discarded

Outcome of Today’s Meeting

Commissioner Stella Kyriakides proposed to extend the deadline, with the new deadlines and conditions outlined above:

“Provided you agree, this targeted amendment will be presented at the beginning of next year.”

Further, Commissioner Kyriakides mentioned additional measures to look more critically at the regulations as a whole. Specifically:  

• • Address structural problems in the regulations
  • Ensure solutions for Orphan devices, so that patients with rare diseases have access to these devices
  • Promote innovation, by launching a pilot program early next year to provide scientific advice from expert panels to manufacturers of orphan and breakthrough devices
  • Provide more support to small-to-medium manufacturers

There was extensive support from members overall of the Council for the postponement of the deadline.

Commissioner Stella Kyriakides closed the discussion by stating:

“We will be following up very quickly and present a legislative proposal at the very beginning of next year.

And this will also be providing a single solution as has been asked.

Of course, as certificates are expiring on a daily basis, we need a bridging measure until that legislative change takes place. So, in the coming days, we will publish a medical device coordination group’s position paper which will be sent out for a uniform approach to applying market surveillance measures to bridge the gap between the expiry of all certificates and the issuance of new certificates.

We will also fund actions to support the implementation of the medical device regulation under the EU for Health program from early next year.

And in ending I will just tell you that by 2027 we intend to undertake a comprehensive evaluation of the regulatory framework for medical devices and should evidence demonstrate that the new rules have any sort of negative impact on the effect of public health or patient safety or on innovation we will be coming forward with proposing further amendments.”

What’s next?

Watch out for the proposed amendment in early 2023.

We will need to see if it will be exactly as proposed by the EPSCO Council or if changes will be made. For example, while there was an overall consensus to delay the MDR deadline, Malta’s Minister suggested a single extension date versus a staggered approach.

In the meantime, today the MDCG already published its Position Paper mentioned by Commissioner Kyriakides, to act as a bridging mechanism for devices with certificates expiring before the legislative amendment is implemented.

MDCG 2022-18 outlines options for MDD/AIMDD devices with expired CE certificates and without MDR CE marking but are still considered safe for use under MDR Article 97(1). Read more: HERE