Regulatory Open Forum

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  • 1.  display languages

    Posted 29-Aug-2022 19:47

    Hello community:

     

    My question is: Text displayed in a MD should be translated on all the EU official languages? Or it can be displayed in English and provide the translation in the instructions for use?

     

    Thanks for your comments,

     

     

     



  • 2.  RE: display languages

    Posted 29-Aug-2022 23:35
    Hello Rocio

    Some things to consider... Who will be using the device? What language(s) do they understand? Are they likely to use the device safely, even when something goes wrong? Will they feel happy buying it?

    Also consider the markets/jurisdictions where the device will be offered, since each country sets its own language rules. Some require the local language(s) for all text. Some require it for safety-related texts while allowing other texts to be in one or more other languages. Some require a local language for home use devices and allow other languages for professional users. Some allow different languages only with special permission.

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    Anne LeBlanc
    United States
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  • 3.  RE: display languages

    Posted 30-Aug-2022 03:32
    Buenos dias Rocio,

    Hope you are doing well.  The current expectation is the languages on screens, displays, computer interfaces are translated to the local language for the operator to interact with the software application.  In most cases, having the Windows international version usually helps alot with this unless the software application has many internal wording or phrases.  Agree with Anne, you have to look at the country where the 'text displayed' such as on a screen or monitor depends on the "professional" aspect as some countries for professional use do accept English.  While other countries all labelling, including screens, displays, monitors, need to be in the local language.

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