EU Medical Device Regulation (EU MDR) – Chapter 6 – Clinical Evaluation and Clinical Investigations

This is a significant and exciting chapter introducing a life-cycle approach to ongoing CE Marking compliance; it is a process, not a project. One output of the clinical evaluation process is demonstrating clinical performance of the medical device, i.e. demonstrating that the device performs as intended and has benefit to patients. Clinical data in support of performance can come from many sources including: clinical literature, trials, usability, post-market clinical follow-up (PMCF), the state-of-the-art, and/or from “equivalent” devices.