The European Commission is definitely aware of the issue (and the MDCG too, see MDCG 2022-11 position paper (
https://medicaldeviceslegal.com/2022/06/20/managing-the-2024-mdr-danger-zone-and-outlines-of-a-potential-solution-in-mdcg-2022-11/)) but the problem is that they do not have a quick solution to solve the problem that they have been warned about for years and is basically baked into the system. Because notitied bodies are generally private entities, they cannot 'create' capacity where there is none at the moment. Some notified bodies have scaled tremendously but still it's not enough to pass the bulge in the system. You can compare the situation to the EU asking all drivers license examination authorities to re-qualify and then also asking all drivers to renew their drivers licenses at the same time - this will create scarcity by necessity. This was an unwise legislative choice if you ask me, and the slow notified blody re-notification process did nothing to help this.
At the moment measures are being designed to ease off on notified body capacity restricting requirements so they may process more applications (a new MDCG position paper to this effect was circulated about two weeks ago) and the Commission and MDCG are (see MDCG 2022-11) exploring other measures as well, among other things I am expecting an implementing act under article 97 (3) MDR to allow manufacturers with an application in the works more time to finish and continue marketing devices even if the (AI)MDD cert has expired during the application procedure.
For companies that still are not on board with a notified body, explore all options such as not going for the usual suspects but rather map which notified bodies have the scope required for your client by using the NANDO database and then approaching all the ones that have the scope you need. Important to check scope because not every notified body has every scope and usually the notified bodies with limited scope are generally not as swamped as full scope ones. Also, find a good consultant in Europe that works with a large number of notified bodies and they will usually have an idea to go to what notified body with what device. My firm works with several of them. A targeted scope oriented approach is more likely to yield results - so whether there is 'a lead' in your case will depend on which notified body your client needs.
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Erik Vollebregt
Partner
Amsterdam
Netherlands
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Original Message:
Sent: 22-Jul-2022 09:30
From: John Minier
Subject: Notified Body Availability
We have 2 clients looking to get CE mark certificates for the 1st time. We have already received "no new clients" from BSI and NSAI. Does anyone know of Notified Bodies taking on new clients?
I don't know if the European Commission is aware of the struggle relatively new companies are going through trying get devices into the EU market.
Please let me know if you have a lead we can follow up on.
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John Minier, RAC
Consultant
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