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  • 1.  MDR DoC Translations - Professional or Lay Use language?

    Posted 17-Jun-2022 17:50
    MDR Article 19(1) states the EU declaration of conformity "shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available." Some regions (e.g. Switzerland, Netherlands) allow English for processional use documents but what about regulatory documents such as the DoC?

    Thanks,
    Mark

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    Mark Mortellaro
    Sr. Principal Regulatory Scientist
    Clarksburg MD
    United States
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  • 2.  RE: MDR DoC Translations - Professional or Lay Use language?

    Posted 18-Jun-2022 01:26
    Hello Mark

    Switzerland does allow English for the DoC. See article 29 of the MedDO:
    https://www.fedlex.admin.ch/eli/cc/2020/552/en

    The Nederlands Medical Devices Decree does not have a similar clause. I might guess that English technical documentation would likely be acceptable to the regulatory authorities since IGJ makes available an English section of their website?
    https://english.igj.nl/medical-technology/market-authorisation/requirements-labelling-instructions
    Although they wouldn't be the only user of the DoC.

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    Anne LeBlanc
    United States
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    Original Message


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