Regulatory Open Forum

 View Only

  • 1.  EUDAMED UDI / Device Registration

    This message was posted by a user wishing to remain anonymous
    Posted 01-Sep-2022 09:15
    This message was posted by a user wishing to remain anonymous

    Hello, 
    I understand the module for UDI / device registration is now planned for 2026.  I am trying to find out if it will be possible to include the IVDR DoC when completing the registration in this module and if so, will it be voluntary / mandatory and publicly available? 

    Thank you in advance.


  • 2.  RE: EUDAMED UDI / Device Registration

    Posted 02-Sep-2022 03:59
    Hello Anon,

    When you speak about date of UDI / device registration in 2026 this is when full compliance needs to be done; see recent timeline published by the European Commission https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf.  The UDI / device registration module already exists today and can be used "voluntarily" - and I use the quotes very liberally as some expect it to be done now for EU MDR/EU IVDR registered products.  But yes it can be used voluntary basis and some fields, data, information, etc., are already available.  In regards to the Declaration of Conformity (DoC), this is supposed to be in the EUDAMED system where the company uploads the DoC for their products, but this is not there ... at least yet.  Even the current modules which are in place like Actor Registration and UDI/Device Registration is still being modified and adjusted.  We hopefully will be able to see a more finalised version in the next year toward end of 2023 - but as you can imagine with a new electronic system there will be adjustments made.

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

    Original Message


  • 3.  RE: EUDAMED UDI / Device Registration

    This message was posted by a user wishing to remain anonymous
    Posted 02-Sep-2022 10:39
    This message was posted by a user wishing to remain anonymous

    Thank you for replying
    Original Message


  • 4.  RE: EUDAMED UDI / Device Registration

    This message was posted by a user wishing to remain anonymous
    Posted 02-Sep-2022 10:21
    This message was posted by a user wishing to remain anonymous

    Eudamed Module 2, UDI/Devices registration, is available for voluntary use; it has been since November 2021. The last time I looked at Module 2's requirements I did not see the DoC listed as one, unless these requirements have been updated. There may be an option to provide the DoC voluntarily. The EC provides extensive documents explaining the modules and their requirements as a good resource. The mandatory UDI compliance date is dependent on the device risk class.
    Original Message


Related Content