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  • 1.  legacy device in Eudamed

    Posted 06-Apr-2022 06:16
    Hello,
    i have a question regarding legacy device.
    Should i upload my UDI in Eudamed now as a legacy device or should wait after my EU MDR certification audit?

    I know if i upload as a legacy device now i will not need to obtain basic UDI from GS1 but will register as  MDD. Therefore, i will have to reregister under EU MDR once i receive the EU MDR cert?

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    Bedwuine Senatus
    Springfield NJ
    United States
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  • 2.  RE: legacy device in Eudamed

    Posted 07-Apr-2022 02:34
    Hello Bedwuine,

    Currently all information provided to EUDAMED is voluntary - there has been no notice of "fully functional" so there is no requirement.  Many companies are needing to get the Single Registration Number (SRN) as part of their Notified Body application.  Also note, there is a difference of Basic UDI-DI and the UDI number so make sure understood - when you say obtain basic UDI from GSI, assuming you are meaning the company identifier and product identifier.  The Basic UDI-DI is assigned internal to the company.

    To answer your question further, because it is voluntary at the moment, the only reason to enter a EU MDD product for UDI is if you are not planning to continue marketing that device, i.e. not transitioning to EU MDR.  This would be for entering vigilance information for a EU MDD product in the Vigilance module (which is not available yet).  Rather then doing things twice, and also might be confusing, you might wait until the products have received their EU MDR certification before uploading device information and UDI into EUDAMED.  Again its voluntary now and the reason for having EU MDD products listed is for vigilance when those products continue to be sold or remain in service (like large equipment or reusable products).

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


  • 3.  RE: legacy device in Eudamed

    Posted 07-Apr-2022 02:34

    Hi Bedwuine,

     

    The legacy device and regulation device are two separate registrations. The registration of legacy devices is not mandatory however if you decide to register your MDD devices this MDD registered device will be available on the public site. The MDD device is then automatically connected to your MDR submission which demonstrates that your device has a track record and history, and this may be useful advertising. Our advice to companies is to get all their data into EUDAMED as soon as possible.

     

    There are two times it is mandatory to register legacy devices:

     

    1. A post-market surveillance and/or a vigilance report ensues; or

    2. By the end of the transition period applicable for device registration, if no equivalent MDR or IVDR device is registered in EUDAMED

     

    You are right about not needing a GS1 Basic UDI for the legacy device. This will be needed when you register your regulation device and the same UDI DI can be used for both legacy and regulation devices.

     

    If you need any assistance with data preparation and validation, and EUDAMED submissions please do let me know as we provide various submission services and EUDAMED training. We have even just launched a "make it go away" service where on your behalf we validate your data against all the EUDAMED rules, advise you on any necessary changes, and submit it to EUDAMED for you.

     

    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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    Original Message


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