MDR Serious incident reporting timelines

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  • #42299
    Paul Gilbert

    For countries where the various sections of the MDR (medical device regulation) come into effect on 26 May 2021, I have the following query.

    My understanding is that the MDR serious incident reporting timelines (2 days, 10 days & 15 days) and criteria would apply from 26 May 2021, but with the reporting destinations being as per the existing requirements (i.e. to the competent authority), since reporting to Eudamed is not possible as it is not yet fully functional. If there are any comments on whether you agree with this, they are welcome.

     

    #43392
    Tom Nichols
    Participant

    This question was discussed at the June 2021 PIPA Live webinar and is available as a recording.

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