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

When developing a clinical evaluation document, the first factor that should be evaluated is clinical investigations. This is because clinical investigations provide the most robust and direct evidence regarding the safety and efficacy of a medical device or intervention. They are typically conducted under controlled conditions with a specific protocol and involve collecting data on how the device performs in a real-world setting or simulated conditions.

Clinical investigations include randomized controlled trials or observational studies, and the outcomes of these studies form the foundation for the assessment of a product's performance. Since they are designed to address specific research questions about the device, including its efficacy and safety in a target population, they offer critical insights that inform subsequent sections of the clinical evaluation document.

While adverse event reports, clinical experience, and literature searches are also important components of the evaluation process, they build upon the fundamental data gathered from clinical investigations. By starting with this type of evidence, the clinical evaluation process can ensure that it is grounded in empirical data, thereby enhancing the rigor and reliability of the overall assessment.