Medical Device Reporting

Medical Device Reporting (MDR) is a regulatory process that requires manufacturers, importers, and healthcare providers to report any adverse events or product issues related to medical devices. This can include serious injuries, malfunctions, or deaths linked to these devices. The goal of MDR is to ensure patient safety and improve the quality of medical devices by identifying problems early. Reports are submitted to government authorities, like the FDA in the United States, to help monitor device performance and maintain public health standards. Through this, potential risks can be addressed promptly, increasing overall safety for users.