Regulatory Open Forum

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  • 1.  Notified Body Availability

    Posted 22-Jul-2022 09:30
    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.

    John Minier, RAC

  • 2.  RE: Notified Body Availability

    Posted 23-Jul-2022 10:47
    Hello John,

    Yes, sadly this is the circumstance today and many Notified Bodies are struggling just to support their existing client certification.  We do not have a list of who or who is not accepting new clients because it is continually changing.  Recently I have heard some groups like G-Med, TUV SUD, or Dekra are looking at new clients.  Start at the top of the list in NANDO and start calling some?  Sorry for maybe making funny question like that, but the whole situation is not funny.  The European Commission is aware, but publicly they say everything is 'on track' - shrugs.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs

  • 3.  RE: Notified Body Availability

    Posted 23-Jul-2022 11:09
    MedTech Europe recently published a study showing the unavailability of notified body services, especially for small and medium size enterprises. Not sure how many businesses are giving up altogether, but it looks like there are a lot of products coming off the market.

    Anne LeBlanc
    United States

  • 4.  RE: Notified Body Availability

    Posted 24-Jul-2022 05:02
    Edited by Erik Vollebregt 24-Jul-2022 05:06
    The European Commission is definitely aware of the issue (and the MDCG too, see MDCG 2022-11 position paper ( 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.

    Erik Vollebregt

  • 5.  RE: Notified Body Availability

    Posted 25-Jul-2022 01:27

    Thanks for the update Erik – any idea when we might expect passage of that new implementing act to allow more time for those with expired MDD certificates?




    Tina O'Brien

    MS, RAC

    Director, Regulatory Affairs



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  • 6.  RE: Notified Body Availability

    Posted 25-Jul-2022 02:14
    I honestly don't know re timing, otherwise I would have been more precise. I haven't seen any stakeholder consultation for it yet, which means that whatever is in the making is not ready yet. After that the implementing act still has to go through the examination prodcedure under the Comitology Regulation pursuant to article 114 (3) MDR ( And that's assuming that my prediction that they're working on an implementing act is even correct - there may be other things in the making too as the MDCG and the Commission are keeping their cards very close to their chests now so it's very hard to have a complete picture. The summer holidays don't help to speed up the process either.

    Erik Vollebregt

  • 7.  RE: Notified Body Availability

    Posted 26-Jul-2022 01:58
    Hello John
    Please try to contact Slovakian NB: 3EC International, Slovakia, that also focuses on foreign clients and recently accepted new clients.

    3EC International a.s.
    Hranicná 18
    821 05 Bratislava
    Phone: +421 (0)2 5831 8343

    During the autumn, the Czech NB :ITC a.s.,  Czech Republic will also receive a license, try to contact them already.

    ITC a.s.
    třída Tomáše Bata 299, Louky, 763 02 Zlín, Czech Republic,
    Contact person: Mr. Tomas Zavisek
    Phone: +420 572 779 955

    Evangelos Tavandzis
    Lead Auditor, Consultant
    Czech Republic

  • 8.  RE: Notified Body Availability

    Posted 26-Jul-2022 13:03
    Edited by Ed Panek 26-Jul-2022 13:04
    We have a class IIa device under MDD and MDR and we have an August/September submission timeframe. We have everything nearly done already, however...

    Our NB in talks with us told us to expect 18-24 months for approval under MDR. That puts us past our MDD cert expiration & unacceptable.

    Part of my gripe is the bottom-up implementation of the MDR. Make drastic sweeping changes, don't understand or provide added supporting infrastructure, release it, and "Let industry and NB figure it out" style management. Meanwhile, it's also the patients (Why MDR was created) who will get punched in the mouth by this laissez-faire plan.

    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets -

  • 9.  RE: Notified Body Availability

    Posted 26-Jul-2022 13:49
    Thanks, everyone for your input.

    The work ahead is significant. The EC, NBs, and manufacturers underestimated what is involved in getting all product lines upgraded to MDR compliance. And no one is taking new companies trying to get into the EU market for the 1st time into consideration. 

    Pointing fingers is not constructive. Neither is ignoring the situation. We need to come to some understanding regarding realistic expectations and timelines. This needs to be addressed sooner rather than later. 


    John Minier RAC
    Consultant, Principal