For medical device manufacturers seeking market approval in the United States or European Union, clinical evaluation report writing has become a critical regulatory and compliance requirement. As global standards evolve and evidence expectations increase across FDA pathways and EU MDR regulations, companies must prepare structured, defensible documentation—including a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER)—to demonstrate device safety, performance, and clinical benefit. Understanding the scope, timing, and workflow helps teams build a predictable roadmap and avoid costly delays during regulatory review.