Regulatory Open Forum

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  • 1.  Certificate withdraw reasons diferentiation

    Posted 5 days ago
    If we have a case where a medical device manufacturer did not want to pay to NB invoices with the changed fees which are doubled without notification (warning), and due to this the NB is threatening to withdraw the MDD certificate, due to this economic dispute. In the past this manufacturer did not have any issues with the product nor has incidents with any of the devices and during previous audits only a few minor NCs. In accordance with the previous, is there a possibility to differentiate a case of withdrawal of certificate due to incidents (vigilance case) and on the other hand due to economic dispute with the NB. This is now very important because the manufacturer is in MDR process with another NB (it is possible because of different regulations), and the manufacturer is willing to apply to CA for extension of certificate and use of Article 97. But if it is not possible to make such differentiation, then application to CA does not makes sense because manufacturer in that case cannot anyhow convince CA to support them.
    Additionally, I would add that such NB dramatically change prices during validity of certificate without previous warning and those prices differ from the one stated in the mutual certification agreement and on their NB web page price list.

    What is your opinion on this kind of issue?

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    Dragan Jovic
    Director of QA and IT
    Nis
    Serbia
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  • 2.  RE: Certificate withdraw reasons diferentiation

    Posted 4 days ago
    Hello Dragan,

    A complicated case. Maybe you can reach out to CA and see what can be done? They will be the best to advise you on this. Regulatory authorities maybe have seen such cases with other companies.

    Good luck.
    Olga

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    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    olga.peycheva@solutionsop.co.uk
    United Kingdom
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  • 3.  RE: Certificate withdraw reasons diferentiation

    This message was posted by a user wishing to remain anonymous
    Posted 3 days ago
    This message was posted by a user wishing to remain anonymous

    If the fee increase is enough to be considered unethical, you might also consider escalating the complaint to the NB accreditation organization. That could help to support the case with the CA.

    Manufacturers should not be subject to price gouging, nor should NBs actively contribute to device shortages.


  • 4.  RE: Certificate withdraw reasons diferentiation

    Posted 3 days ago
    Yes, thank you for this input. I will keep this in mind, because as I see this will end in the court, and such proposal is valuable.
    I completely agree. Thank you for the comment.

    Kind regards
    Dragan

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    Dragan Jovic
    Director of QA and IT
    Nis
    Serbia
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  • 5.  RE: Certificate withdraw reasons diferentiation

    Posted 3 days ago
    Thank you Olga. We are now preparing a letter to a CA and will do this way. I agree with you it is smart way.

    Kind regards
    Dragan

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    Dragan Jovic
    Director of QA and IT
    Nis
    Serbia
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  • 6.  RE: Certificate withdraw reasons diferentiation

    Posted 3 days ago
    Cross - posted https://connect.raps.org/discussion/certificate-withdraw-reasons-diferentiation-1

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