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  • 1.  EU MDD Language Abbreviation Standard

    Posted 01-Dec-2020 16:44
    Hi everyone,
    I tried checking the official journal of the EU to find the right standard for language abbreviations. I could not find anything related on the list. Can someone please suggest what standard is used and if it should be harmonized?

    ISO 3166 or ISO 639-1?

    Thank you!
    Akanksha

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    Akanksha Asbe
    Regulatory Affairs Specialist II

    Clinton MA
    United States
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  • 2.  RE: EU MDD Language Abbreviation Standard

    Posted 02-Dec-2020 02:37
    Hello Akanksha,

    Personally, I always wondered why there are two standards which seem to have the same information.  In my day-to-day work, I use ISO 3166 because in fact it is not so much a "standard" as a continually maintained database which you can find here: https://www.iso.org/obp/ui/#search.  In the labeling of medical devices when indicating the different languages, we use the two-letter code from the ISO 3166 database though ISO 639 series is specific to language designation.  So just make sure to use both?  I think in general if you are talking about common languages from countries, these codes have stayed the same for years and years, i.e. Germany DE or France FR.  Internally often in my labelling generation procedures, I have cited both standards as sources of information.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: EU MDD Language Abbreviation Standard

    Posted 02-Dec-2020 02:57
    Yes, the iSO 3166 database (and its alert service) are very useful for tracking country designations​, as countries merge, split, or change their names.

    The list of languages doesn't change as much. https://en.wikipedia.org/wiki/List_of_ISO_639-1_codes

    There are a few countries (e.g. France and Germany) where the two-letter lower-case language code for the official language happens to be the same as the two-letter upper-case country code, but that's not typical.

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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    Original Message


  • 4.  RE: EU MDD Language Abbreviation Standard

    Posted 02-Dec-2020 04:28

    Hello Akanksha,

    I propose to use ISO 20417 (once it is published) .

    The  ISO 20417-FDIS points in section 5.3.1 Language identifiers to ISO 639-X and in section 5.3.2 Country identifiers to ISO 3166-1.
    In both cases the plain text name for the language or country  is also OK.



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    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany
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    Original Message


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