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  • 1.  Box change and UDI change

    Posted 17-May-2021 22:07
    Dear all,
    We are facing to a query and I need please you point of view.
    We have a  change on the box dimension and type and we wondering if this change required a new UDI even if the product inside remain the same.

    From my understanding, we should put in the final packaging ( carton box) the UDI of the device , should the box have its own UDI that will change when we have a new box?
    Eg. in the past we sold the device in two different carton box with one UDI related to the device (a system) and now we want to us one carton box which will include all the component. In this case do we nee to use a new UDI or not?

    PS: the new box was validated tough out a transport and handling testing.

    Thank you in advance for your reply.

    Rgds,

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    Nadine Adia
    Quebec QC
    Canada
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  • 2.  RE: Box change and UDI change

    Posted 18-May-2021 02:51
    Hello Nadine,

    Without seeing the actual packaging configuration and how contents of the box are made - it is quite difficult to give a definitive answer as with UDI even there are different ways this could be done.  As an example, the UDI number can be the same for Packaging Level 1 (direct label on a pouch) and Packaging Level 2 (carton or box with 'x' pouches) if the products are say uniform.  Or you could have different UDI between Packaging Level 1 and Packaging Level 2 by showing the different packaging levels.  Remember UDI numbering is from the perspective of the user so they can easily differentiate between products if there is an issue.  If the UDI number at all levels of packaging will clearly identify the product, then it might not be necessary to have multiple UDIs at different packaging levels.  In your case, you might want to change the UDI number or have a different one because if the contents of the carton box is going to be different from one configuration to another, again from the user perspective it will help identify which "version" of packaging configuration they are using.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
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    Original Message


  • 3.  RE: Box change and UDI change

    Posted 18-May-2021 02:59
    Hi Nadine,

    Although I'm not entirely sure I got your question right, I'll try to put in my 2 cents.

    Original situation:
    Components A and B, in boxes A and B, together make system C. Both boxes A and B are labelled with UDI of system C.

    New situation:
    Components A and B, combined in box  C, together make system C. Box C is labelled with UDI of system C.

    If above is correct, the new situation at least seems better then original. But there might be work to be done.

    A few considerations to make:

    UDI is intended to identify the product/device throughout its existence. How do you tell boxes A and B apart in original situation?

    It sounds like the user is allowed to / needs to assemble A and B into C.
    That would infer that components A and B shall also be identifiable when separated, meaning A and B would require their own UDIs A and B.

    Is the change considered a major/significant change? If the before and after version are completely exchangable, it might not be.significant. Consult the local guidance(s) for target market(s) to formally  determine (and document) this.
    If significant: a new UDI (C2) would be needed. Also keep in mind that local rules may vary, so some changes may be significant for US, but not for EU (or vice versa).

    If there is a single system C in box C (a 1 on 1 relation between package and device), then UDI C for the component may be used for box C.
    If you pack different quantities (2, 5, 10,  100...), each of them shall need their own UDI (D, E, ...).

    No definitive answer to your questions, but I hope this still helps you further.

    Regards,



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    Bart J
    Netherlands
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    Original Message


  • 4.  RE: Box change and UDI change

    Posted 18-May-2021 04:07
    Hello Nadine

    You need to look into the specifications of your Standards provider.  For example if you are using GS1 then they have a 20% rule.  So if the dimensions or weight of the carton level change by 20% or more then you would need to issue a new GTIN and therefore UDI.  This is for Supply Chain reasons so that space can be allowed for storing products and transportation weights can be calculated.  The change in code would notify the Stakeholders that there is a change to the product.

    Kind Regards

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    Jenny Young
    MDR Project Manager
    ConvaTec
    United Kingdom
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    Original Message


  • 5.  RE: Box change and UDI change

    Posted 20-May-2021 13:39
    Thank you all for this precious response , it's now clear for me.
    Very helpful.
    Rgds

    ------------------------------
    Nadine Adia
    Quebec QC
    Canada
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    Original Message


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