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  • 1.  UDI and Catalogue Numbers

    This message was posted by a user wishing to remain anonymous
    Posted 18-May-2023 13:05
    This message was posted by a user wishing to remain anonymous

    Hi All, 

    I am working on  Hardware + Software product.  Hardware is a medical device on it's own.  Software is a medical device on it's own, but needs to be installed on this specific hardware to achieve it's intended purpose.  The Software will be integrated into the hardware for testing, so compatibility will be tested completely. 

    The hardware will be registered separately EU, Software will be registered Separately, So each of these products will have it's own Catalogue Number and it's own UDI. 

    However, for ease of manufacturing and commercialization, The company intends to have a catalogue Number for Hardware+Software, thus this product will have it's own UDI.  But this catalogue Number will not be registered with any health agency.

    Is this acceptable?

    Thanks!



  • 2.  RE: UDI and Catalogue Numbers

    Posted 19-May-2023 09:56
    Edited by Manan Hathi 19-May-2023 09:57

    Hello, 

    I am assuming the software and hardware have their own independent intended uses that are slightly different from each other to warrant classifying them separately. If their intended uses are the same, and they depend on each other for their function, then I would suggest the software is simply a component of the medical device and does not need its own registration / classification / UDI, etc. 

    If they are indeed two separate devices, you could consider naming the combination of hardware + software as a kit for logistical purposes. Whether or not the kit needs to be registered with regulatory authorities in a UDI database would depend on several factors. The questions to ask are: is the combination for logistical purposes only, or will it be shipped to the customer as a kit? What about trade / compliance - if it crosses customs, would customs be looking for the UDI in a database? For EU, would the conmbination be considered a System or Procedure Pack (System/Procedure Packs and producers have their own UDI requirements - there is an MDCG guidance on that you can look up). 

    These are some of the ideas you can explore - the right answer will depend on the specific intended uses and situations...

    All the best!



    ------------------------------
    Manan Hathi RAC
    Sr. Manager, Regulatory Affairs - Software
    Flower Mound TX
    United States
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    Original Message


  • 3.  RE: UDI and Catalogue Numbers

    Posted 19-May-2023 10:33

    Hello Anon,

    Unique Device Identification (UDI) has requirements associated with how the are assigned, used, and applied to finished product, but there is also quite a bit of flexibility in how a company can assign a UDI.  Of course, this depends on the packaging configuration as again there are some minimum requirements.  The UDI number assignment is always from the perspective of the user allowing them to have the traceability to the finished device or different configurations.  In your situation where this is being used internally and not registered with any regulatory agency, really there is no reason to assign a UDI.  However, if your organisation might use these in the future there is nothing to preclude for getting a number concerning the hardware + software.  UDI numbers can be assigned to different configurations or packaging of devices, though again it really depends on how the user/consumer views the product.



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


  • 4.  RE: UDI and Catalogue Numbers

    Posted 19-May-2023 13:59

    We have used this strategy successfully many times (and there are many advantages to it - particularly as the software is often ungraded separately from the hardware - requiring a new UDI).  I also think the MDR/IVDR recognizes that "embedded" software is independent of the physical device - from MDCG 2019-11:
        "Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a "medical device" in the MD
          or IVDR, regardless of whether the software is independent or driving or influencing the use of a device."

    Based on the limited information. the only other question I would have is whether the combination should also be considered a system and/or configurable device - requiring its own UDI. I do not believe it should - but this is something we have been debating.



    ------------------------------
    Jay Crowley
    Vice President, Medical Devices and UDI Practice Lead
    USDM Life Sciences
    Baltimore MD
    United States
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    Original Message


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