Medical Device Reporting (MDR)

What is medical device reporting?

Medical device reporting (MDR) is a post-market surveillance tool used by the U.S. Food and Drug Administration to detect potential device-related safety issues, monitor device performance, and contribute to benefit-risk assessments of medical devices.

Under MDR, mandatory reporters (e.g., device user facilities, manufacturers, importers) must submit reports to the FDA for adverse events and product problems. Patients, healthcare professionals, and caregivers can also submit voluntary reports on serious adverse events that may be attributed to the medical device, along with product quality issues, use errors, and therapeutic failures.

Under MDR regulations, medical device manufacturers, importers, and device user facilities must also establish a system that allows for prompt identification, investigation, documentation, reporting, and filing of severe device-related injury, death, or malfunction.

Why is MDR important for healthcare?

By providing information on failures and poor functioning of medical devices, the FDA can take action to improve these devices and patient safety. Furthermore, through the MDR regulation, medical device manufacturers have a system in place to address any failures and correct the errors to limit their likelihood of happening again, leading to better patient care.