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.