RUT test design for IFU testing

During the planned Marketing Authorisation Application (MAA) a Readability User Test was performed on the proposed package leaflet. The package leaflet met all  the predefined criteria. Still in the D150 LoQ requested IFU testing. An additional RUT (2*5) on the IFU was requested by EMA. KHN did not receive this request to test the IFU part in the questions before. In close calloboraton with the sponsor it was decided a full 2*10 RUT test on the IFU part of the PiL was sufficient show consumers/users understood the IFU. Noteworthy is the fact the actual device was not presented during the study. (HF/UE validation and risk analysis already done though). This study concerns the Readability User Test of the IFU.

The study will be completed mid Q2 2018, feedback on dossier expected by Q4 2018.

For more information or updates please contact us.