Medical Device Reporting (MDR)

 Medical Device Reporting (MDR) is a regulation implemented by the US Food and Drug Administration (FDA) that requires manufacturers and importers of medical devices to report to the FDA any incidents in which their device may have caused or contributed to a death or serious injury, or in which the device malfunctioned and could cause or contribute to a serious injury if the malfunction were to recur. The purpose of the MDR regulation is to provide the FDA with information about the performance of medical devices in the marketplace, so that the agency can identify potential safety issues and take appropriate regulatory action.


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