When developing a clinical evaluation document for a new device, which factor should be evaluated first?

In the context of developing a clinical evaluation document for a new medical device, starting with clinical investigations is crucial because these investigations provide foundational data on the device's performance and safety in a controlled environment. Clinical investigations, including clinical trials, are designed specifically to gather evidence about how a new device behaves in real-world scenarios, measure its effectiveness, and assess its safety profile. This primary source of data is essential for establishing a baseline understanding of the device's capabilities and limitations.

A thorough analysis of clinical investigations allows regulatory professionals to understand the context and scope of the clinical evidence that has been generated for the device. It sets the stage for further evaluation of adverse event reports, clinical experience, and literature search, as these elements will often reference or build upon the results of the clinical investigations. By prioritizing investigations, the clinical evaluation document gains a solid foundation that informs and validates subsequent analyses and conclusions.