Clinical Evaluation Report (CER)

A Clinical Evaluation Report (CER) is a detailed document that assesses the safety and performance of a medical device. It summarizes evidence from scientific studies, clinical trials, and existing data to demonstrate that the device is effective and safe for patient use. The CER helps regulators and healthcare providers understand the device's benefits and potential risks, ensuring it meets regulatory standards before reaching the market. Essentially, it's a comprehensive review that validates the device's clinical performance based on current scientific proof.