A clinical evaluation report (CER) is the document in which clinical data on a medical device is systematically collected and assessed, demonstrating suitability for the intended use.
Core components of the report
- Description and scope of the device
- A search of the available literature
- Assessment of equivalent device data
- Clinical investigation data, if any
- Benefit–risk analysis and conclusion
Throughout the process
The CER is a living document that is updated while the product is on the market. A planned approach makes it easier to stay consistent with the other parts of the technical file.
This article is general information, not a diagnosis or treatment recommendation. Consult a physician for a personal assessment.
