Regulatory Open Forum

 View Only

  • 1.  Clinical evaluation evidence

    This message was posted by a user wishing to remain anonymous
    Posted 09-Aug-2021 10:19
    This message was posted by a user wishing to remain anonymous

    Hi Everyone,

    We have a class IIb device which has got the 510(k) and is under process of EC certification under MDR. To show equivalency under clinical evaluation, we have one published literature of the equivalent device other than that there are no published literature available. Our plan is to collect the data from field (US) and use this information in our CER. Also we don't have plans to do PMCF studies as there are no residual risks identified for this device.

    Can this approach be acceptable by NB?

    Thanks,
    RAPS member


  • 2.  RE: Clinical evaluation evidence

    Posted 10-Aug-2021 09:19
    No.

    regards

    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------

    Original Message


Related Content