Clinical Evaluation Report

A clinical evaluation report (CER) is a document that summarizes the clinical data and analysis of a medical device. The purpose of a CER is to demonstrate that a medical device is safe and effective for its intended use, based on a comprehensive evaluation of available clinical data.

The CER is a requirement for obtaining regulatory approval to market a medical device in many countries, including the European Union. The CER provides an overview of the clinical performance of the device, including data on safety, effectiveness, and any adverse events or risks associated with its use.

The CER should include the following components:

1. Introduction: This section should provide an overview of the medical device, its intended use, and the clinical data that will be presented in the report.
2. Clinical data: This section should provide a comprehensive summary of the clinical data that has been collected for the device. This includes data from pre-clinical studies, clinical trials, post-market surveillance, and any other relevant sources.
3. Clinical evaluation: This section should provide an analysis of the clinical data, including an assessment of the safety and effectiveness of the device for its intended use. The evaluation should also consider any risks associated with the device and any steps taken to mitigate those risks.
4. Conclusion: This section should provide a summary of the clinical evaluation, including any recommendations or actions that may be required based on the findings.
5. Bibliography: This section should include a list of all the references cited in the report.

The CER should be prepared by a qualified clinical evaluator with expertise in the specific medical device and its intended use. Clinical Evaluation Consultants The evaluator should have access to all relevant clinical data and should conduct a comprehensive analysis of that data to ensure that the device is safe and effective for its intended use.

In conclusion, a clinical evaluation report is an essential document that provides an overview of the clinical data and analysis of a medical device. It is a crucial component of the regulatory approval process and is necessary to demonstrate that a medical device is safe and effective for its intended use.