MDR single report exemption and ASRs: Coming to an end for most reporters

The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical device manufacturers, to identify and monitor adverse events (deaths, serious injuries, and certain malfunctions) involving a manufacturer's medical device.

Ultimately, the goal behind MDR reporting is transparency to facilitate timely postmarket surveillance of medical device performance to drive necessary corrective action.

Read More: MDR single report exemption and ASRs: Coming to an end for most reporters


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