What is the purpose of a Medical Device Reporting (MDR) system?

The purpose of a Medical Device Reporting (MDR) system is primarily to report adverse events related to medical devices. This system is crucial for ensuring patient safety and maintaining the integrity of medical device regulation. When healthcare professionals, manufacturers, or patients report incidents involving medical devices—such as malfunctions or injuries—regulatory authorities can collect this critical information, analyze it, and take necessary actions to prevent further occurrences.

The MDR system plays a significant role in post-market surveillance, allowing the monitoring of devices after they have been approved and are in use. It helps stakeholders identify trends, potential hazards, and the overall safety and effectiveness of medical devices over time. Ultimately, the data collected through the MDR system can inform regulatory decisions, enhance device design, and improve patient outcomes by addressing potential issues proactively.