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  • 1.  Suspended CE Certificate

    This message was posted by a user wishing to remain anonymous
    Posted 15-Nov-2019 13:06
    This message was posted by a user wishing to remain anonymous

    Hello, 
    We have a single CE certificate for multiple products. NB has issued NC for one of the products from the list and suspended the certificate. Only one product in the CE certificate has NC issued. However, as they are part of the same certificate, suspension of the certificate meant that we cannot sell all the products. We would like to limit the certificate suspension to only the product that has NC and be able to sell the other products. Is there some guidance available? Also, does NB have the authority to cancel all the products' CE cert based on one product's NC?

    Thank you in advance.


  • 2.  RE: Suspended CE Certificate

    Posted 17-Nov-2019 22:13
    Edited by Ivan Vecerina 17-Nov-2019 22:21

    Hi,

    It is probably not helpful to seek to find guidance documents to argue against your NB.  It's best to speak with them, and to seek to find a solution with them.

    Have you provided a root cause analysis for the current NC? Are you able to correct the NC immediately?  Do they have reasons to believe that the issues similar to the present NC may affect your other products?

    If they are confident that the other products are not affected, while the affected product is sufficiently different and the issue cannot be solved quickly, they would be able to issue a new CE certificate that only lists the other products.



    --
    Ivan Vecerina
    i.vecerina@a-cbi.com
    Chief Scientific Officer / Head of Compliance
    Switzerland




  • 3.  RE: Suspended CE Certificate

    Posted 18-Nov-2019 06:21
    You definitely need to open a dialogue with your Notified Body - as much as we all on this forum can give advice, thoughts, or rebuke to a NB nonconformity being fair or unfair - ultimately they are the one managing your certificate(s).  This is one reason as an organisation I would would keep separate product families on separate CE Certificates - while it may cost more - if one product has an issue then all are affected.  This is definitely a conversation you need to have with your NB.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 4.  RE: Suspended CE Certificate

    Posted 18-Nov-2019 17:40
    Richard, just curious, on the question of an NB's authority to cancel certification...do you know if there is anything in the MDD/MDR that would prevent an NB from cancelling a certificate, just because it feels like it?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 5.  RE: Suspended CE Certificate

    Posted 19-Nov-2019 06:32
    Julie,

    Is that a loaded question? lol  In honesty, I am not a lawyer and if it got to that point, a company would want a lawyer.  I would have the opinion a Notified Body can not just suspend or cancel a CE Certificate without having substantial evidence the company is not following the requirements.  I do know there is much more authority and responsibility under the EU MDR for Notified Bodies and Competent Authorities alike to ensure safety and performing product are on the market in the EU.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------



  • 6.  RE: Suspended CE Certificate

    Posted 19-Nov-2019 12:11
    Edited by Julie Omohundro 19-Nov-2019 12:13
    Ah, but what is it loaded with? :)

    I think it's food for thought when it comes to entering into a contractual agreement with a notified body.

    As May 2020 draws closer, I'm watching more and more companies absorb the apparent reality that there is nothing in the MDR that says a company gets to have a notified body just because they want one.  I'm not sure they have yet progressed to the awful realization that this might not be just for now, but forever.  I think this has been something of a shock to the system for companies that deal mostly with FDA, which is legally obligated to review all submissions, and also to clear/approve/whatever them, if they contain the appropriate data.

    Going from not being required to accept a client to not being prohibited from withdrawing a certificate is something of a leap, but it does not strike me as an impossible one.  I'm not knowledgeable about EU law, but I agree that, should this happen, the company would want to contact a lawyer.  What I'm not sure about is whether there would be anything for a lawyer to pursue under the new regulations, or whether this would simply be a contractual matter.  In that case, it would be unlikely to end well for the company, if the contract had no language that barred the NB from doing this.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 7.  RE: Suspended CE Certificate

    Posted 18-Nov-2019 11:45
    ​Assuming that the other products on your certificate are not components of the same system to which the suspended product belongs, and assuming these products are not interoperable, it seems the easiest course would be to ask your NB the administrative change of re-issuing your cert for the approved products while working to remediate the deficiency in the unapproved product.

    Best of luck!

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    Maureen Dawson RAC
    Regulatory Affairs Associate
    San Diego CA
    United States
    ------------------------------