The Medical Devices Introductory Course 2020

Clinical Evaluation - the main documents

THE CLINICAL EVALUATION REPORT (CER)

The Organisation for Professionals in Regulatory Affairs

Typical CER contents

• Executive summary – short summary for internal purposes • Scope – which devices are covered, detailed description of devices, identification of relevant GSPRs • Clinical background, current knowledge, state of the art (derived from literature search) • Statement on type of evaluation (i.e. whether conformity is based on clinical data or clinical data is not deemed appropriate) • Demonstration of equivalency (if claimed) • Clinical data generated and held by the manufacturer

• Clinical data from literature • Appraisal of the clinical data • Analysis of the clinical data in relation to identified GSPRs • Conclusions

The Organisation for Professionals in Regulatory Affairs