Regulatory Open Forum

 View Only

  • 1.  UDI-DI

    This message was posted by a user wishing to remain anonymous
    Posted 17-Nov-2022 16:46
    This message was posted by a user wishing to remain anonymous

    Hi RAPS folks,

    We have a class IIb device with different pack sizes. The product uses 1 basic UDI-DI. However, does each pack size should have a unique UDI-DI assigned?

    Appreciate you responses on this!


  • 2.  RE: UDI-DI

    Posted 17-Nov-2022 17:28

    Yes. The Basic UDI-DI is for the family. It does not go on the package or label. Each family member gets its own UDI-DI which does go on the package or label.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 3.  RE: UDI-DI

    This message was posted by a user wishing to remain anonymous
    Posted 18-Nov-2022 12:33
    This message was posted by a user wishing to remain anonymous

    Thanks Dan! This is helpful. 

    Just to follow-up, if 2 SKUs have same pack size, but sold through different sales channel, how does the UDI-DI then gets assigned?
    Original Message


  • 4.  RE: UDI-DI

    Posted 18-Nov-2022 12:55

    The UDI-DI is an attribute of the device and is independent of the sales channel.

    If you 2 SKUs are the same then they will have the same UDI-DI. If you have different catalog numbers for different sale channels, that does not change the UDI-DI.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 5.  RE: UDI-DI

    Posted 18-Nov-2022 09:00
    Good Morning...

    It is the responsibility of Regulatory at my company.  We have an SOP for Unique Device Identification and one for EUDAMED Registration.  These were written after a gap analysis to determine if our QMS was compliant with MDR and making sure we had covered FDA QSR, CMDR and ISO13485:2016.

    We had been using GS1 and entering our products in GUDID, but did not have it called out in a QMS procedure.

    Best regards,

    ------------------------------
    D Michelle Williams
    VP - Operations
    United States
    ------------------------------

    Original Message


  • 6.  RE: UDI-DI

    Posted 18-Nov-2022 10:32
    Yes, each distinct kind of package gets a distinct UDI-DI, aligned with its distinct catalog number.

    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------

    Original Message


  • 7.  RE: UDI-DI

    This message was posted by a user wishing to remain anonymous
    Posted 18-Nov-2022 12:33
    This message was posted by a user wishing to remain anonymous

    HI Anne! Thanks for the feedback. What's the catalogue number? Is it same as SKU number used for inventory purposes?
    Original Message


  • 8.  RE: UDI-DI

    This message was posted by a user wishing to remain anonymous
    Posted 18-Nov-2022 12:33
    This message was posted by a user wishing to remain anonymous

    Hi D Michelle, Thank you for the insight! 

    How are you managing Basic UDI-DI and UDI-DIs without UDI-DI module being active on EUDAMED?
    Original Message


  • 9.  RE: UDI-DI

    Posted 19-Nov-2022 12:01
    Hi Anon

    If you haven't read it yet, I recommend the MDCG's UDi Q&A document. Among other things, it gives some explanation of why different packages need different UDIs.

    https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf

    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------

    Original Message


Related Content