Medical Device Reporting (MDR) is a regulatory reporting framework for certain adverse events and product problems involving medical devices.
In the U.S., MDR requirements support timely notification of serious injuries, deaths, and device malfunctions that could lead to serious harm if they recur. In device studies, sponsors and sites must have clear processes for capturing, evaluating, and reporting reportable events according to applicable rules and timelines. MDR data supports ongoing safety surveillance and informs regulatory actions such as safety communications or design changes. Clear MDR workflows help protect participants and support compliant safety oversight for device-related research.