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  • 1.  EUDAMED Test version

    This message was posted by a user wishing to remain anonymous
    Posted 11-Oct-2019 08:45
    This message was posted by a user wishing to remain anonymous

    Hi All,

    Just wondering if anyone tried the test version of Eudamed yet?

    I was on the second step to enter the authorized rep information and do not know what "mandate validity dates" and "mandate document" is. Any guidance?

    Thanks!
     



  • 2.  RE: EUDAMED Test version

    Posted 12-Oct-2019 09:36
    Could you provide the information to gain access to the test version of EUDAMED?


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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: EUDAMED Test version

    Posted 12-Oct-2019 11:50
    I am not aware of a test version of EUDAMED.  Though due to the utter lack of transparency by the EC this does not surprise me there is some test website out there a few people have access to for testing.

    Please confirm or provide a link.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: EUDAMED Test version

    Posted 12-Oct-2019 15:09
    The "mandate validity dates" and "mandate document" seem obvious. But I haven't seen any mention of open beta testing.​

    The first module was examined early in 2018 by 20 selected user representatives: https://www.emergobyul.com/blog/2018/04/eudamed-update-actors-module-testing

    According to the rolling plan, at the end of summer they were preparing a contract for an independent audit to determine if it meets specifications and is "fully functional" so it can go live, so maybe that audit has begun.  https://ec.europa.eu/docsroom/documents/36663

    The web address for the public access site has been announced, but it isn't up yet.  https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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    Original Message


  • 5.  RE: EUDAMED Test version

    Posted 13-Oct-2019 18:47
    Eudamed has bee in test for some time now, with the participation of specific invited organizations in what is know as "EUDAMED Playground", but it's not open. The participating organizations had to agree not to share any information upon accepting participation, so many line or whatever would not be in accordance with the requirements they are obliged to meet. 

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    Marcelo Antunes
    Regulatory Strategy Consultant
    São Paulo
    Brazil
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    Original Message


  • 6.  RE: EUDAMED Test version

    Posted 14-Oct-2019 08:49

    I have not seen the test version, but I'm pretty sure I understand the requirement.

    You are probably testing functional specification FS-ACT-005: Manage association (mandate) between non-EU manufacturer and AR from the version 4.1 (the public version) of the spec. In particular FS-ACT-005.01 is, "Enable non-EU Manufacturers to enter Mandate information and to indicate whether the AR may or not submit incident reports and their corrective actions (Serious incident report, FSCA, FSN, PSR and Trend report) for devices covered by the mandate". FS-ACT-005.02 is "Enable Manufacturers to Change Mandate scope and/or dates".

    Article 11 requires that a non-EU manufacturer designate a sole authorized representative. Article 11(2) says, "The designation shall constitute the authorized representative's mandate, it shall be valid only when accepted in writing by the authorized representative and shall be effective at least for all devices of the same generic device group."

    I suspect the fields are asking you for the text of the mandate and its effective date.

    This is in the restricted portion of EUDAMED, so I'm not sure who will have access to the text of the mandate.

     

     



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


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