The MDR introduces more stringent requirements for medical device manufacturers, emphasizing patient safety and a clinical evidence-based approach to the confirmation of the benefit-risk determination for each device. Under the MDD, the term PMCF was associated with formal post-market studies and only considered necessary for a few high-risk or novel devices. Under the MDR, PMCF is an integral part of the post-market surveillance (PMS) process applicable for all devices. Another important change with the MDR is that PMCF is defined as a continuous process which updates the clinical evaluation. To place a product on the market in Europe under the MDR is therefore a commitment to continue to gather information, including clinical data, for the lifetime of the device. Further insights are available in the white paper on device lifetime co-authored by NAMSA and BSI.