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 CER is an important part of the Technical File/ Design Dossier for a medical device. The medical writer conducts the literature review and compiles the CER with input from design engineers, regulatory specialists, safety scientists and quality experts.
The aim of this course is to better understand what is involved in developing a CEP and writing a CER to Medical Device Regulation (MDR) 2017/745 standards. The course will focus on the increased requirements of MDR and will cover the clinical evaluation process, literature reviews and post-market surveillance (PMS) and benefit-risk assessment.
