ERP License in India-- Mandatory Requirements for Medical Device Reporting (MDR) Medical Device Reporting (MDR) in the US mandates the reporting of adverse events and malfunctions related to medical devices to ensure their safety and effectiveness, and it is governed by the FDA\'s 21 CFR Part 803. The FDA mandates manufacturers, importers, and device users to report medical device-related adverse events causing death, serious injury, or major health risks. Manufacturers, importers, and device user facilities are required to report device malfunctions posing a potential risk of death or serious injury. Timely Reporting: Reports must be submitted to the FDA promptly, usually within 30 days of awareness, and within 5 days for device malfunctions with potential for serious harm or death. User Facility Reporting: Healthcare facilities must report device-related deaths to manufacturers and the FDA, along with reporting serious injuries to manufacturers. Manufacturer Reporting: Manufacturers must submit MDRs for events they become aware of, including reports from healthcare professionals, user facilities, patients, and various sources. FDA Form 3500 Series: MDR reports are submitted using the FDA Form 3500 series; these forms capture crucial details about device, event, and patient data for FDA reporting. Unique Device Identifier (UDI): Manufacturers must include the Unique Device Identifier (UDI) in MDR reports for precise medical device identification. Follow-Up Reporting: Mandatory follow-up reports are necessary if new information arises subsequent to the initial filing by manufacturers. Medical Device Reporting Overview Who’s Required to Report MDR? MDR (Medical Device Reporting) is required by regulatory authorities like the FDA, involving manufacturers, importers, and user facilities reporting adverse events and malfunctions related to medical devices. Manufacturers: Companies that design, manufacture, assemble, or package medical devices. Importers: Companies or individuals who bring medical devices from a foreign country to their country. User Facilities: User facilities like hospitals must report incidents with medical devices causing death or serious injury as part of MDR regulations. Distributors: Distributors are involved in medical device distribution but may have distinct reporting obligations compared to manufacturers and importers under MDR regulations.