clinicalevaluationreport

  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: 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. 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 tr...