Medical Device Reporting (MDR)
Medical Device Reporting (MDR) is the FDA requirement that manufacturers, importers, and facilities report device-related deaths, serious injuries, and certain malfunctions. It creates a surveillance trail enabling the agency to monitor safety signals and act on problematic devices.
What is Medical Device Reporting (MDR)?
Medical Device Reporting (MDR) is the U.S. Food and Drug Administration regulatory mechanism that obligates device manufacturers, importers, and certain user facilities to notify the agency when a device may have caused or contributed to a death or serious injury, or when it has malfunctioned in a way that could lead to harm if it recurred. The reports feed a structured database the FDA uses for post-market safety surveillance.
Each category of reporter faces distinct obligations and timelines. Manufacturers, for instance, must investigate and submit reports within defined windows, while user facilities have their own narrower duties focused on deaths and serious injuries.
Why does MDR matter?
Because devices reach the market without the years of pre-approval study that drugs often undergo, real-world reporting is a critical early-warning system. Aggregated MDR data lets the FDA detect safety signals, order corrections or recalls, and protect patients from defective or poorly performing products.
For facilities that use surgical and diagnostic equipment, understanding MDR obligations is part of responsible device stewardship. Timely internal reporting of adverse events supports both regulatory compliance and the broader safety feedback loop that keeps the device supply chain accountable.
- mdr fda
- what is medical device reporting
- medical device reporting requirements
- mdr reporting
- fda medical device reporting
- medical device reporting meaning