Regulatory Open Forum

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  • 1.  Label translations

    Posted 06-Nov-2023 17:55

    Hi all,

    I am working on an EU MDR submission for a kit consisting of more than one product. I wanted to understand if we are supposed to translate the name of each product on the label for the EU region and other countries where we are planning to ship the product.

    Thanks!



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    Shikha Malik
    Sr. Regulatory Affairs Specialist
    Frisco TX
    United States
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  • 2.  RE: Label translations

    Posted 07-Nov-2023 07:05

    Shikha,

    it is generally understand product names do not need to be translated on labelling.



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


  • 3.  RE: Label translations

    Posted 07-Nov-2023 10:15
    Edited by Mbaboh Ngah-Wanneh 08-Nov-2023 00:41

    Hello Shieka,

    Sorry, I posted the wrong response to your question. But like Richard and Armin already said Product names need not be translated.

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    Mbaboh Ngah-Wanneh
    Graduate Student RAS
    St.Cloud State University
    Plymouth
    MN
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    Original Message


  • 4.  RE: Label translations

    Posted 07-Nov-2023 12:12

    I concur with Richard.  I am not aware that any member state requires to translate the Product name. 

    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armin.beck@suntrixmedical.com



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    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armin.beck@suntrixmedical.com
    ------------------------------

    Original Message


  • 5.  RE: Label translations

    Posted 08-Nov-2023 04:39

    Hi Shikha,

    maybe one additional caveat: If the names contain information needed by the user to understand the contents of the package or the function/intended use of the device(s) that is not available elsewhere on the labelling, then I think a translation would be required.

    For a more detailed answer additional information on the type of kit, the contents and the names would be needed.

    Best regards

    Christoph



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    Christoph Kiesselbach
    Reutlingen
    Germany
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    Original Message


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