Regulatory Open Forum

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  • 1.  EUDAMED

    Posted 08-Feb-2022 11:17
    What organizational identification documents are required to be uploaded during the EUDAMED registration?

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    Rhea Johny
    Woodbury MN
    United States
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  • 2.  RE: EUDAMED

    Posted 09-Feb-2022 03:30

    Hi Rhea,

     

    It is not mandatory to provide such a document however some competent authorities are asking for it, some are happy with an official company registration document that shows the company at the address you are registering, others are looking for the same notarized. The European Commission did not specify any specific document. To be safe I would suggest a notarized document that shows the address and the company name.

     

    Best regards,

     

    Richard Houlihan

    @eudamed.com

     

     

     

    EirMed Ltd

    Brussels, Belgium | Sofia, Bulgaria

    t:   +359 2 492 8458

    e:   richard.houlihan@eudamed.com

     

    EudaMed.com

          

     

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  • 3.  RE: EUDAMED

    Posted 09-Feb-2022 05:26
    Hello Rhea,

    Just note, this has to do with the Competent Authority requesting the SRN number and not anything which gets uploaded or reviewed in the actual EUDAMED system.  It is dependent on the Competent Authority as issues in the past with companies are making request of companies to ensure they are legitimate.

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