A clinical evaluation plan outlines the systematic approach to assess the safety and performance of a medical device throughout its lifecycle.

Key components include defining the device's intended use, identifying equivalent devices, selecting appropriate clinical data sources, determining evaluation methods, and specifying data analysis techniques.

A CEP establishes clear objectives, endpoints, and criteria for patient selection, ensuring robust evidence generation. Ethical considerations, risk management, and data quality assurance measures are integrated, while post-market surveillance strategies are outlined. Ultimately, a well-structured clinical evaluation plan ensures comprehensive, robust clinical data, and regulatory-compliant assessment of the device's clinical benefits and risks.