The MDR Paradox: What The December 2025 Easing Takes Off Your Desk, And What You Still Have To Collect

The European Commission’s December 2025 proposal to simplify the MDR removes a report, not the data. The report it cuts is the separate PMCF evaluation report for Class III and implantable devices. The duty to collect clinical data proactively across a device’s lifetime stays, as do the PMCF plan requirements. For the teams that own PMCF plans, that leaves a practical problem: choosing a collection method that holds up with a notified body.

Here, we explain which PMCF obligations the proposal alters and which it leaves untouched. We also explore the position of legacy devices and of any claim that PMCF is not applicable. Learn how survey-based methods compare with registries, prospective studies, and retrospective data collection. Then use the eight-point checklist provided to choose the method best suited to your device and build a PMCF strategy you can defend at your next notified body review.