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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