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  • 1.  UDI Label on Medical Device itself

    Posted 16-Oct-2023 15:23

    Can we put CE logo along with UDI label?

    Just trying to remove extra step for assemblers and reducing the chances of missing CE mark labeling. 

    Please provide your valuable feedback from FDA and EU MDR perspective



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    Arslan Rahat
    QARA Manager
    Toronto ON
    Canada
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  • 2.  RE: UDI Label on Medical Device itself

    Posted 16-Oct-2023 18:32

    Hello Arslan

    US and EU don't have strict rules about the number of separate adhesive labels applied to product or package.

    But where will you put the EC REP and other information?



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: UDI Label on Medical Device itself

    Posted 17-Oct-2023 03:27

    Arslan,

    While the US and EU do not have requirements about labels, "over-labelling" is generally frowned upon.  From your picture it seems like the CE Mark is a separate label being put on top of the other label.  The concern with over-labelling is they can come off easier and have a perception these are not under any type of control.  If you are trying to remove steps for the assemblers in the manufacturing process, why not incorporate the CE Mark directly into the current label - so there is only one (1) label?  Thus it does help making sure this one little sticker label is indeed not forgotten. 



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


  • 4.  RE: UDI Label on Medical Device itself

    Posted 17-Oct-2023 05:16

    I agree that neither the US nor EU have rules about what information needs to go on which label.

    However, note that the UDI shown is not compliant - as GS1 does not recognize QR code for UDI implementation.



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    Jay Crowley
    Vice President, Medical Devices and UDI Practice Lead
    USDM Life Sciences
    jcrowley@usdm.com
    +1-805-880-2591
    Baltimore MD
    United States
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    Original Message


  • 5.  RE: UDI Label on Medical Device itself

    Posted 18-Oct-2023 02:29
    Edited by Roger Christinger 19-Oct-2023 04:07

    I don't completely agree with Jay's comment.

    Both, the US and EU have specific minimum requirements about what needs to be placed on device labels (c.f. EU MDR 2017/745 GSPR 23.2 and US 21 CFR Part 801). Depending on the device type there may be additional requirements e.g. from IEC 60601-1.

    GS1 does recognize QR codes (although it has additional requirements for its implementation) among other variants of 1D and 2D codes (c.f. clause 5.1.1 of their specs). But for direct marking of medical devices it is specified that a data matrix shall be used as per clause 2.1.8 of their General Specifications (https://ref.gs1.org/standards/genspecs/).

    Thanks, Anne LeBlanc, for your below clarifications.

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    Roger Christinger
    Lead RA/QM Consultant
    Zühlke Group, Switzerland

    www.zuehlke.com
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    Original Message


  • 6.  RE: UDI Label on Medical Device itself

    Posted 18-Oct-2023 07:56

    "Datamatrix" and "QR code" are two different types of 2D barcode, not interchangeable.

    https://www.gs1.org/standards/barcodes/2d



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    Anne LeBlanc
    United States
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    Original Message


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