This article examines clinical evaluation under the EU MDR from the perspective of clinical experts from three notified bodies. They anticipate new guidance on clinical evaluation, with an update of MEDDEV 2.7/1, rev. 4, and a definition of orphan devices and clarification on their use in the EU. The article provides useful information for manufacturers and highlights published expert scientific opinions aimed at notified bodies. It also discusses the expanding use of real-world data and evidence (RWD and RWE) for confirming the safety and performance of medical devices, especially in postmarket clinical follow-up (PMCF).
