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  • 1.  Translation of device name

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2023 16:19
    This message was posted by a user wishing to remain anonymous

    Hi everyone, I have a question regarding the labeling requirements for medical devices in the EU. I am wondering if the device name or trade name needs to be translated into the local language(s) in the EU countries where the device will be marketed. I have read the MDR and MDD , but I'm still unclear on this point. Could someone please clarify if device names must be translated, or if there are any exceptions or guidelines for brand names? Thanks in advance for your help!



  • 2.  RE: Translation of device name

    Posted 23-Feb-2023 00:32

    Anon,

    The simple answer is no.  While there is nothing specific in regulation or guidance, it has been generally accepted that Trade Names, Company Name, or other proper names do not need translation.  Now, if there is the device type stated somewhere, this would need to be translated, but not the actual product brand/trade name.



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


  • 3.  RE: Translation of device name

    Posted 23-Feb-2023 02:47

    Hi, agree with the previous answer: product names should not be translated.

    Moreover, as per MDR, the label must contain 'the details strictly necessary for a user to identify the device'. In the case where no product description or picture as been added to the label as the product name obviously identifies the device (e.g. Blade, Saw, ...), I would translate it.



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    Lydia Bedre-dine
    Lyon
    France
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    Original Message


  • 4.  RE: Translation of device name

    Posted 23-Feb-2023 09:19

    We work with over a hundred medical device companies translating their IFUs and manuals. Clients typically do not translate the product name unless there is a descriptor included. For example if the device name were Thartat CRT™ System, only the word system would be translated. However it should be noted that some languages will require that the word order be changed due to the grammatical structure of the language. So for this example, French would be Système Thartat CRT™. 



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    Nancy Kellen
    VP - Client Services
    Atlanta GA
    United States
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    Original Message


  • 5.  RE: Translation of device name

    Posted 23-Feb-2023 11:33

    Hi , if you have device description as part of the name, that will require translation.



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


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