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A Clinical Evaluation Report (CER) is a safety and assessment report of a medical device. It is based on the clinical data collected by conducting clinical investigation and other studies on the device. The purpose of a CER is to demonstrate the safety and efficacy of a device without posing a potential risk or threat to the patients. CERs are required for bringing medical devices into the Europe market and to obtain CE marking certificate for the intended device. It can be submitted to the Europe health authority in the form of a technical file.

CER and Required Data Elements

  • General information related to the medical device such as the name of the device and manufacturer
  • Physical and technical description of the device and its application
  • Brief description of the therapeutic and diagnostic claims
  • Types of data and their clinical evaluation
  • Review and summary of the clinical data
  • Description of analyses of the assessment processes
  • Conclusion of the safety and efficacy

As part of the post-market surveillance, a CER for medical devices must be updated on a regular basis. Any change that might affect the functioning of the device must be mentioned clearly in the updated CER. Failing to do so may raise compliance issues. A CER must be updated:

  • Every year
  • Whenever a piece of new information, which may affect the current evaluation, is encountered
  • Every 2-5 years, if the device is well established

The Regulatory scenario of the European Medical Device Registration (MDR) is extremely dynamic and so are the regulations pertaining to CER. Therefore, to keep up with these regulations and to author compliant CERs, companies must consult Regulatory experts. To know more about authoring and compiling CERs, reach out to Freyr at sales@freyrsolutions.com.