Regulatory Open Forum

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  • 1.  Confirm MDD license during transition

    Posted 25-Sep-2023 07:38

    Hello folks,

    I recently joined this new company and I would like to confirm the MDD license. I logged into EUDAMED, and there is only information for MDR.

    I would like to know how to get the information for our MDD correctly - should I contact our NB, which I have already did?

    Thank you for sharing your expertise.



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    Lulu Zhang
    PRRC/Management Representative
    Head of Quality and Regulatory Affairs
    Canada
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  • 2.  RE: Confirm MDD license during transition

    Posted 25-Sep-2023 09:49

    Hi Lulu

    Yes, if this company doesn't have a copy of the CE certificate and related information in the files, the NB should be able to help. Some of the NBs also have relevant information online, which can be handy. For example, TÜV Rheinland's "Certipedia":

    https://www.certipedia.com/

    https://www.certipedia.com/certificates/69244207?locale=en

    You may also want to check if this new company has written an appropriate procedure for record keeping already.



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    Anne LeBlanc
    United States
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  • 3.  RE: Confirm MDD license during transition

    Posted 25-Sep-2023 10:56

    Hey Anne

     Thank you for your reply!



    ------------------------------
    Lulu Zhang
    PRRC/Management Representative
    Head of Quality and Regulatory Affairs
    Canada
    ------------------------------