The new Regulation 2017/746 for In Vitro Diagnostic medical devices was published in May 2017 with a 5 years transitional period and application date from May 26th 2022: among the key changes introduced by the regulation, the new requirements for Clinical Evidence are some of those of greatest importance (ref. CHAPTER VI).
Clinical evidence is required as a combination of sufficient amount and quality of clinical data and performance evaluation results pertaining a given device to allow a qualified assessment of whether the device achieves the intended clinical benefit and safety, when used as intended by the manufacturer.
For this purpose, performance evaluation has been now re-defined as a continuous process for collection of clinical evidence to demonstrate the scientific validity, analytical performance and clinical performance of that device for its intended purpose throughout the whole life-cycle.