RegScan - by Enhesa software

The medical device reporting (MDR) requirements of 21 CFR 803 apply to manufacturers, importers, distributers, and device user facilities in the United States. Such facilities are required to report adverse device-related events to the Food and Drug Administration (FDA) or the device manufacturer, and occasionally to both. These requirements are supplemental to the quality system requirements of 21 CFR 820 in Quality Suite MEDICAL DEVICES Good Manufacturing Practices for Medical Devices checklist.

The starting point are the national regulations of the United States and the European Union.