How to Prepare Clinical Evaluation Report (CER) under EU MDR 2017/745

Blog Image
How to Prepare Clinical Evaluation Report (CER) under EU MDR 2017/745

The clinical evaluation of medical devices is a procedure for demonstrating the safety and efficacy of the devices. The documentation of the clinical evaluation process is called a Clinical Evaluation Report (CER). The CER holds a significant position when placing or distributing medical devices in the European Union (EU). The report aims to establish the device’s intended benefits for users when weighed against the associated risks.