Clinical investigations and performance studies are critical in ensuring the safety and performance of medical devices and in vitro diagnostic, medical devices. A clinical investigation involves systematically assessing a medical device used for humans, aiming to identify any potential risk and assess its performance and safety. A performance study evaluates the performance of in-vitro diagnostic devices by analysing their ability to provide accurate and reliable test results.
These studies are essential for generating clinical evidence and enabling informed decision-making by manufacturers, notified bodies, competent authorities, and healthcare professionals.