Notification of termination of the Clinical Investigation

The IVD-manufacturer, or his legal representative, is obliged to inform the FAMHP of the termination - premature or not - of a performance study via

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.

Last updated on 13/04/2021