The IVD-manufacturer, or his legal representative, is obliged to inform the FAMHP of the termination - premature or not - of a performance study via ct.rd@fagg.be.
Subject of the notification: End of performance study notification - IVDPSxxxxxx.
The manufacturer must attach a report with a critical review of all data collected during the performance study.
Notification of the end of a performance study is not subject to a fee and is therefore free of charge.