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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:
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- 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?