Clinical evaluation
Short definition
Clinical evaluation is the systematic and planned process of continuously generating, collecting, analysing and assessing the clinical data on a device, to verify its safety, performance and clinical benefit.
In plain language
It is defined in Article 2, point 44, and regulated in Article 61 and Annex XIV of Regulation (EU) 2017/745. It applies to all classes, including Class I. It can be based on scientific literature, clinical investigations and post-market data, and is updated throughout the life of the device.