Adverse Event Reporting

Adverse Event Reporting is the regulated process by which manufacturers, importers, and user facilities document and submit information about events where a medical device may have caused or contributed to death, serious injury, or malfunction that could lead to serious harm if it recurred. In the United States, AER is primarily fulfilled through the FDA’s Medical Device Reporting (MDR) requirements under 21 CFR Part 803 and submitted via MedWatch or electronic gateways. 
 
Effective AER requires a timely intake of adverse events' critical information, complaint investigation, health hazard evaluation, and regulatory decision-making within defined timelines (e.g., 30-day, 5-day reports). For example, Due to a software malfunction, the medical device is generating incorrect diagnostic output. It could delay treatment and is reportable even if no injury occurred. A robust AER process supports compliance, trend detection, and corrective actions. It must be integrated well with complaint handling, CAPA, and postmarket surveillance systems.