Introduzione
Clinical evaluation of a medical device is a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer. The clinical evaluation plan (CEP) describes how the clinical evaluation will be performed, including objective and measurable clinical benefits, acceptability parameters for the benefit/risk profile, determination of what will be considered ‘sufficient clinical data’, what data will be collected and how any knowledge gaps might be addressed. The CEP is regularly reviewed and updated and forms the basis of the clinical evaluation report (CER).
The aim of this course is to explore what is involved in developing the CEP, including initial literature reviews and instructions for use (IFU).