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  • 1.  SiMD UDI for EU

    This message was posted by a user wishing to remain anonymous
    Posted 28-Mar-2024 16:44
    This message was posted by a user wishing to remain anonymous

    Hi all,

    Does anyone know what the labeling requirement for a class I SiMD in EU? Would we need a separate software UDI to be applied in the software if a UDI is on the computer itself.  The device is a marginal MedDev similar to a DVR. 

    We were looking at the device as a system where one cannot be used without the other.

    Any guidance, information, or advice would be greatly appreciated.

    Thank you



  • 2.  RE: SiMD UDI for EU

    Posted 29-Mar-2024 04:31

    A lot of questions, acronyms and unknowns in this question that this quite the puzzle. Let's unpack:

    • is the software separately a device? In that case it would need its own UDI. If the software forms a device with the computer, the UDI can be for the whole software plus computer device. However, you use the term SiMD, which suggests that the software is an integral component of the hardware, which would point to the combination of the two being a device. SiMD is not a defined concept under the MDR though, so something like a class I SiMD would not exist under the MDR as a regulatory concept.
    • have you used the term system as defined in the MDR and used in article 22 MDR or are you using the term colloqiually? In first case it would be likely (but not necessary) that you see the software and computer as separate devices (otherwise no system in the system definition) and the devices each need their own UDI. In the latter case good luck because since system is a defined term in the MDR, people will assume that you mean what the defined term means (and not what you may think you mean). This can get you in all kinds of regulatory misunderstandings and ensuing issues / enforcement.
    • What do you mean by a marginal MedDev? This is not a regulatory concept in the MDR. Whether something is a (medical) device is a binary, and not marginal, criterion.
    • If one cannot be used without the other there is the possibililty that one is an accessory of the other, especially if the hardware is similar to a DVR. But it may also be a general purpose piece of hardware, depending on its intended purpose. Or since you use the term SiMD, this suggests that the software is integrated in the hardware, which would point to a single device (i.e. the combination of the hardware and software).

    WIth this information it's impossible to provide a precise answer to the question. Consider reading MDCG 2023-4 on software-hardware combinations (https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf) and asking the question again. My guidance is to practice regulatory language hygiene as much as possible and describe the subject of the question as functionally as possible, without using acronyms.



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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


  • 3.  RE: SiMD UDI for EU

    Posted 30 days ago

    You can decide yourself what works best, but then you have to apply the rules consistently. 

    In the case of a device that is using or driven by software, you can either certify the whole device including its software. Downside is that an update to the software may result in having to certify the whole deivce again. You may also decide to add in the intended purpose of the device that is intended to run specific software and in that of the  software that it should be used together with that particular device. In that case, hardware and software each have their own Basic UDI-DI and technical documentation and they may be in different risk classes. If one is update, but the other remains the same, only one device needs new technical documentation and, if relevant, certification.

    In general I would advise to split up in the case of complex and/or innovative devices and consider the device as one in the case of relatively simple and mature technology. 



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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    Original Message


  • 4.  RE: SiMD UDI for EU

    Posted 27 days ago

    Anon,

    You would probably need to clarify how the definition of a Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD) are being applied to your system/product/finished device.  There seems to be some different terms or explanation uncertainty about using SiMD.  If the computer is integrated for sole use with an electromechanical device, then there probably is one complete UDI.  If there is separate software, SaMD, which interacts with an electromechanical device containing its own SiMD, then there would probably be two UDI numbers assigned.  You might want to seek some further expert opinion specific to your device configuration for how the system is established and applicable for UDI assignment.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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    Original Message


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