Regulatory Open Forum

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  • 1.  EUDAMED - Actor registration

    Posted 30-Oct-2020 06:12
    Dear RAPS members,

    Has anyone applied for an early actor registration in EUDAMED?
    EUDAMED Company Registration and User Management * Eudamed Company Registration 

    Looking forward to your valuable feedback.

    Kind Regards,

    ------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
    ------------------------------


  • 2.  RE: EUDAMED - Actor registration

    Posted 31-Oct-2020 07:42
    Soumya, the actor registration module is not open for use until 1 December 2020.

    ------------------------------
    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Consulting
    Clinical Studies - Regulatory - Quality Systems
    Rome, Italy
    +39 06 578 2665
    rgray@donawa.com
    www.donawa.com
    ------------------------------

    Original Message


  • 3.  RE: EUDAMED - Actor registration

    Posted 02-Nov-2020 03:29
    Thanks, Roger! I was a bit confused as the link said one can apply for early registration to avoid delays.

    Regards,

    ------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
    ------------------------------

    Original Message


  • 4.  RE: EUDAMED - Actor registration

    Posted 02-Nov-2020 03:12
    Hi Soumya, 

    See the link for the actors registration details.  It provides flowcharts for your information, depending on what type of actor you are.
    Very informative...also a video for step by step guidance. 

    https://ec.europa.eu/health/md_eudamed/actors_registration_en

    ------------------------------
    Colleen Powell
    Director of Regulatory Affairs
    Gloucestershire
    United Kingdom
    ------------------------------

    Original Message


  • 5.  RE: EUDAMED - Actor registration

    Posted 02-Nov-2020 03:28
    Thanks, Colleen! The link was indeed very helpful.

    Regards,

    ------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
    ------------------------------

    Original Message


  • 6.  RE: EUDAMED - Actor registration

    Posted 03-Nov-2020 04:23
    What I find interesting is all of this information now readily available, but more interesting seems this will actually happen on 1 Dec.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


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