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FIH Clinical Trial - assessment of CIP

  • 1.  FIH Clinical Trial - assessment of CIP

    This message was posted by a user wishing to remain anonymous
    Posted 15-Sep-2022 15:25
    This message was posted by a user wishing to remain anonymous

    Hello
    Since the expert panel under EU MDR is not available yet, how are businesses assessing their Clinical Investigation Plan for novel devices with future decision makers of CE mark?

    I have spoken to three Notified Bodies and I have been told that consultation is not possible, KOLs may be an avenue but we know that they are not the decision makers later, Competent Authorities has been suggested as well but with the caveat that their feedback may not be deemed appropriate at time of Dossier submission to NB.

    This is for a  novel device with novel science. So input is truly desired by company. Is everyone really just hoping their CIP works?