Regulatory Open Forum

 View Only

  • 1.  EUDAMED - Organization ID Document

    This message was posted by a user wishing to remain anonymous
    Posted 29-Dec-2021 09:22
    This message was posted by a user wishing to remain anonymous

    Hi All,

    Not sure if anyone knows or can elaborate for me on this question. When registering in EUDAMED (Non-EU Mfr) in the Actor Identification section, it asks for an upload document - Organization Identification Document (a document that shows the company exists or is registered). What document is this specifically asking for?

    Thanks!


  • 2.  RE: EUDAMED - Organization ID Document

    Posted 30-Dec-2021 10:27
    i believe the document is the mandate you signed with your EU rep

    ------------------------------
    Bedwuine Senatus
    Springfield NJ
    United States
    ------------------------------

    Original Message


  • 3.  RE: EUDAMED - Organization ID Document

    Posted 31-Dec-2021 04:56

    The "Organization Identification Document" is not the mandate signed with the European Authorised Rep, this is a different document such as a business registration certificate. It is not mandatory. The mandate is required at a different part of the form.

     

    If anyone needs assistance registering their companies and managing their users. Eudamed.com offer a service to cover this. And also a short training course covering it: https://eudamed.com/index.php/product/eudamed-registration-training/

     

    Best regards,

     

    Richard Houlihan

    @eudamed.com

     

     

     

    EirMed Ltd

    Brussels, Belgium | Sofia, Bulgaria

    t:   +359 2 492 8458

    e:   richard.houlihan@eudamed.com

     

    EudaMed.com

          

     

    The content of this email is confidential and intended for the recipient specified in the message only. It is strictly forbidden to share any part of this message with any third party, without the written consent of the sender. If you received this message by mistake, please reply to this message and follow with its deletion, so that we can ensure such a mistake does not occur in the future. 

     

     




    Original Message


  • 4.  RE: EUDAMED - Organization ID Document

    Posted 30-Dec-2021 15:28
    We loaded the local registration documentation for our Legal Manufacturer addresses.  
    Total of 3 attachments are mandatory:
    1.  Declaration Document in pdf format (Blank available on Actors registration page.)
    2. Signed mandate with AR
    3. Legalization paperwork

    ------------------------------
    Stacey Henning
    Principal Specialist, Regulatory Affairs
    Waukegan, IL United States
    ------------------------------

    Original Message


  • 5.  RE: EUDAMED - Organization ID Document

    This message was posted by a user wishing to remain anonymous
    Posted 03-Jan-2022 23:45
    This message was posted by a user wishing to remain anonymous

    Thanks All
    Original Message


Related Content