Medical Device Reporting (MDR) is a system established by the U.S. Food and Drug Administration (FDA) to monitor the safety and performance of medical devices. It requires manufacturers, importers, and device user facilities (such as hospitals and nursing homes) to report adverse events, product malfunctions, and serious injuries or deaths related to medical devices.
The MDR system helps the FDA track potential safety issues, identify defective products, and implement corrective actions such as recalls or safety warnings. Patients and healthcare providers can also voluntarily report adverse events through the MedWatch program, contributing to public health protection.
MDR plays a crucial role in patient safety and medical device regulation by ensuring that faulty or hazardous devices are identified and addressed promptly. It allows the FDA to assess risks, issue safety communications, and mandate recalls when necessary to prevent further harm.
For manufacturers and healthcare providers, compliance with MDR requirements helps maintain transparency, accountability, and regulatory approval for medical devices. The system also fosters continuous improvement in medical technology, ensuring that devices meet high safety and performance standards before and after they enter the market.