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European regulation for in vitro medical device (2017/746)

  • 1.  European regulation for in vitro medical device (2017/746)

    Posted 05-May-2021 02:42
    Hello all,
    I have a question regarding the European regulation 2017/746 (IVDR) is it possible for a software considered as an in vitro diagnostic medical device to have in its destination two different types of users, that is professional and layperson and where can I find the justification for yes or no?
    Thank you very much for your answers
    Have a nice day

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    Pascale
    France
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