A Clinical Evaluation Report (CER) is a document that summarizes the clinical evaluation of a medical device. The purpose of the CER is to provide evidence that the device is safe and effective for its intended use, based on a review of all available clinical data.
The CER is a key part of the technical documentation required for CE marking in the European Union and is also required by regulatory authorities in other regions. The CER should be updated periodically throughout the product lifecycle to reflect new clinical data and changes in the regulatory landscape.
The CER typically includes a review of the scientific literature, data from clinical trials and other studies, post-market surveillance data, and any other relevant clinical data. The report also includes a critical evaluation of the data, an assessment of the clinical benefits and risks associated with the device, and conclusions regarding the safety and efficacy of the device. The CER must be prepared by a qualified individual with expertise in clinical evaluation, and must be based on sound scientific principles and methodologies.