Clinical Evaluation Report (CER)

The Clinical Evaluation Report is a mandatory document that needs to be created by medical device manufacturers who want to distribute a product in the European market. It presents the conclusions of the clinical evaluation. The data comes from the current device's clinical investigation or other studies on substantially equivalent devices. 

The main purpose of this document is to prove that the medical device achieves its intended use without any further risks to users and patients. 

How does structured content authoring help? 

The back and forth between different departments that takes place in the document creation and review stage, and the exchange with the notified bodies and other regulatory bodies, can be significantly improved when using an online tool that allows granular access control for everyone involved in the process. 

A structured content authoring tool, where authoring and reviewing can be done concurrently, is a tool that can reduce time-to-market and significantly decrease errors throughout the writing process.

Key benefits

  • Make sure the report content can be easily edited and commented upon by any third party within an agency or notified body 
  • Import industry-specific taxonomies and ensure the use of approved medical conditions’ denominations consistently throughout your documentation 
  • Make sure critical data such as existence of a hazard is a strictly controlled piece of content that doesn’t get altered in the authoring and reviewing process