An Overview of Clinical Evaluation for Medical Devices

A Clinical Evaluation Report (CER) documents the clinical evaluation of your medical device. A CER consists of analyzed clinical data that was collected either from a clinical investigation of a medical device or the results of other studies on substantially equivalent devices. The CER demonstrates that the device achieves its intended purpose without exposing users and patients to further risk. Clinical evaluation reports are required for all medical devices in Europe. Medical device manufacturers must submit the CER to the notified body as an attachment to the European CE technical file. The technical file is an essential step to obtaining CE marking for a medical device, required to market medical devices in Europe.