Regulatory Open Forum

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  • 1.  BUDI Assignment

    Posted 09-Apr-2021 18:07
    Hi ,

    I would like to understand the process for BUDI assignment. How does the BUDI gets assigned? 

    - Does it depend upon the product class and intended use?
    - Can we have a same BUDI if the device class is same but differs in there intended use? 
    - Is there any step by step guidance available to consult for BUDI assignment?

    Thanks!

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    Shikha Malik
    Regulatory Affairs Specialist II
    Dallas TX
    United States
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  • 2.  RE: BUDI Assignment

    Posted 10-Apr-2021 05:50
    Hello Shikha,

    First, there is no guidance on Basic UDI-DI or BUDI or B-UDI assignment, though there is some information about Basic UDI-DI in relation to UDI in the Functional Specification https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_eudamed_fs_v4_1_en.pdf and the FAQ on legacy devices https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/legacy_dvc_management_en.pdf.  Though I can say the second document is confusing and raises more questions about the BUDI than it answers.

    Simply put you should have a BUDI assigned per device or device family.  So if you have one device, one model, then there would be 1 BUDI.  If you have one device, 15 models then there could be 1 BUDI.  If you have 5 device families with each device family having 5 models, then there could be 5 BUDIs.  This is up to the organisation to define for each of their devices or device family.  Thus it is very important the device family is clearly defined and understood within the company's product portfolio.  The BUDI is going to be a basis for linking many things together in EUDAMED once it is fully functional so you will want to establish this clearly in advance within your own company.

    The BUDI can be up to 13 characters long either Alpha or Numeric depending on how you are assigning the GMN Number ... yep another number to keep track of for the product family and UDI assignments.  There is a GMN Number calculator, as an example, offered by GS1 which shows how the BUDI is used to generate the GMN Number https://www.gs1.org/services/gmn-generator.  The assignment of the BUDI does not only depend on the Intended Use, but this is probably the main determination because you should have 1 BUDI assigned per 1 device/1 device family.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: BUDI Assignment

    Posted 12-Apr-2021 03:48
    Hello Shikha

    MedTech Europe has issued guidance on the Basic UDI-DI allocations - https://www.medtecheurope.org/resource-library/medtech-europes-guidance-on-basic-udi-di-assignment/.

    The main things that you need to remember are that if the products meet the following criteria then they can be allocated to the same BUDI:

    1. Same Risk Class.
    2. Same Intended purpose
    3. Same essential design and manufacturing process.

    As long as the products meet all of those criteria they can be in the same BUDI family group.

    One other thing to bear in mind, and this is within the guidance from MedTech Europe, is that essentially if the products meet the criteria above then they should also be in the same technical file, so I always add this as a criteria when assessing BUDIs.

    You are able to have numerous BUDIs in one technical file, however you cannot have the same BUDI across two technical files.

    I hope this helps.


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    Jenny Young
    MDR Project Manager
    ConvaTec
    United Kingdom
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  • 4.  RE: BUDI Assignment

    This message was posted by a user wishing to remain anonymous
    Posted 12-Apr-2021 11:11
    This message was posted by a user wishing to remain anonymous

    We have a handful of similar devices, all same class same intended use. But with different history, different technologies.
    The current EC certificate issued by our notified body has a single description for this category.
    Although that certiicate is under MDD, we reasoned that it makes sense that they no should have same BUDI too.

    So you may have a look at your current certificates to see how things are bundled there.

    That said, we are not yet sure what to do with the accessories though.
    They support the same intended use of this class IIb family (and under MDD were considered part of the system).
    But under MDR they will be classified in their own right as a class I. So having them under same BUDI feels a bit odd as it will then be a mixed bag of classifications.