Clinical Evaluation Report

What is a clinical evaluation report?

A clinical evaluation report (CER) is a document that outlines the conclusions of a medical device’s clinical evaluation. Clinical evaluation reports include clinical data on either a specific manufacturer’s medical device or equivalent devices.  

There are three steps to a clinical evaluation report: 

  1. Medical device manufacturers identify clinical data. 
  2. Medical device manufacturers appraise the relevance, quality, applicability, and significance of the data. 
  3. Medical device manufacturers use collected data to communicate conclusions in the clinical evaluation report. 

Medical device manufacturers must regularly update their clinical evaluation reports once their devices are on the market.  

Why are clinical evaluation reports important to healthcare?

A clinical evaluation report is important to healthcare because it confirms that a medical device has achieved its intended purpose. It also indicates that the medical device does not expose patients and other users to further risk.