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  • 1.  Field Service notice translation

    This message was posted by a user wishing to remain anonymous
    Posted 18-May-2020 09:18
    This message was posted by a user wishing to remain anonymous

    Hello ,

    Needed advice..

     Does a FSN need to be translated in all the member state languages? Who is responsible for / generally undertakes this translation , the importer /distributor or the manufacturer ?


  • 2.  RE: Field Service notice translation

    Posted 19-May-2020 04:11

    It is clear from the EU MDR a Field Safety Notice (FSN) needs to be in at least one Member State language.  As you can imagine this is going to be dictated by a factor of items and requirements from different sources including local language requirements (yes these do exist), Notified Body, Competent Authority, and you customers - including distributors.  While the FSN needs to be in one Member State language, think more about customer service where the FSN should be understood by the local readers including distributors and end-users.  I would definitely recommend having an internal process and procedure defining how you handle this as a company.  Because you may only require translation where the actual FSCA is occurring in each Member State - not all Member States.

    Richard Vincins RAC
    Vice President Global Regulatory Affairs