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  • 1.  EU overview of language requirements

    Posted 21-Jan-2024 05:22

    Hi all,

    the EU just published overviews over the language requirements of the Member States for MDR and IVDR that can be found here.

    This should be helpful to identify the respective requirements, although it also shows that national adaptation of the Regulations is not perfect - there are some empty fields or entries marked with "Recent information is not available for the country" (which is strange for a list completed by the responsible Authorities).

    Best regards, Christoph



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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  • 2.  RE: EU overview of language requirements

    Posted 22-Jan-2024 06:14

    Thanks for posting this Christoph !



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
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    Original Message


  • 3.  RE: EU overview of language requirements

    Posted 22-Jan-2024 07:13

    Thanks for posting Christoph. It is a very helpful (and long overdue) collated piece of information from the Commission.

    It should be noted that:

    1. There is a caveat/warning in both documents that highlights that the Commission cannot guarantee accuracy and don't take responsibility for the contents. 
    2. as well as the gaps in the table that Christoph has mentioned, some of the cells of the table are completed based on guidance from the respective competent authority (at this time) rather than an explicit requirement in the national implementing legislation.


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    Ed Ball
    Manager, Intelligence & Innovation
    United Kingdom
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    Original Message


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