[Home](/)/[Resources](/resources)/US Medical Device Reporting USMDR Reporting # US Medical Device Reporting FDA's Medical Device Reporting (MDR) system requires manufacturers to report adverse events. Understanding reportable events, timelines, and documentation is essential for compliance. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fus-medical-device-reporting) At a glance Key requirements 4 Reportable events 3 FAQs 5 ## Key requirements ### Medical Device Reporting (MDR) Manufacturers must report device-related deaths, serious injuries, and malfunctions to FDA within specified timeframes. **Applies to:** Medical device manufacturers and importers ### Death Reporting Device-related deaths must be reported to FDA within 5 working days of becoming aware. **Applies to:** All device-related deaths ### Serious Injury Reporting Device-related serious injuries must be reported to FDA within 30 calendar days of becoming aware. **Applies to:** All device-related serious injuries ### Malfunction Reporting Device malfunctions that could cause death or serious injury must be reported within 30 calendar days. **Applies to:** Reportable malfunctions ## Reportable events ### Death Any death of a patient or user where the device may have caused or contributed to the death. **Timeline:** 5 working days ### Serious Injury Injury or illness that is life-threatening, results in permanent impairment, or requires medical intervention. **Timeline:** 30 calendar days ### Malfunction Device failure that could cause or contribute to death or serious injury if it were to recur. **Timeline:** 30 calendar days ## Reporting process 01 Identify Reportable Event Determine if the event meets MDR criteria for death, serious injury, or malfunction. 02 Investigate Conduct investigation to understand the event and determine if the device caused or contributed. 03 Determine Timeline Determine reporting timeline based on event type (5 days for death, 30 days for injury/malfunction). 04 Submit Report Submit MDR report to FDA through eMDR system within required timeframe. 05 Maintain Records Maintain records of investigation and reporting for required retention period. ## Common compliance mistakes Missing reporting deadlines - late reports can result in enforcement action Not investigating thoroughly - must determine if device caused or contributed Missing reportable events - must have systems to capture all potential events Inadequate documentation - investigation and reporting must be documented Not training staff - staff must recognize and report reportable events Underestimating seriousness - err on the side of reporting if uncertain ## Frequently asked questions ### What events must be reported under MDR? MDR requires reporting of device-related deaths, serious injuries, and malfunctions. Deaths must be reported within 5 working days. Serious injuries and malfunctions must be reported within 30 calendar days. The device must have caused or contributed to the event. ### How do I determine if an event is reportable? Determine if the event is a death, serious injury, or malfunction. Then determine if the device caused or contributed to the event. If both criteria are met, the event is reportable. When in doubt, report the event to FDA. ### What is the difference between 5-day and 30-day reporting? Device-related deaths must be reported within 5 working days. Serious injuries and malfunctions must be reported within 30 calendar days. The shorter timeline for deaths reflects their seriousness. ### Do user facilities have reporting requirements? Yes, user facilities (hospitals, clinics) must report deaths to FDA and to the manufacturer. They must report serious injuries to the manufacturer. Facilities have their own reporting requirements under MDR. ### What records must be maintained for MDR? Manufacturers must maintain records of investigations, reports, and related documentation. Records must be maintained for the required retention period (typically 2-5 years depending on record type). Records must be available for FDA inspection. **Disclaimer:** This guide provides general information about MDR requirements. Event-specific determinations require analysis of FDA regulations. Always verify current requirements with FDA resources or qualified compliance professionals. πŸ‡ΊπŸ‡Έ US roadmap for medical devices Every standard, document, and test that applies β€” free, no account required. See your free roadmap[ Want an expert to take medical devices through πŸ‡ΊπŸ‡Έ US compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course β€” $199](/courses/17-fda-medical-device-registration-510k-hardware-startups)[Prefer to read? Get the book β€” $24.99](/books/17-fda-medical-device-registration-510k-hardware-startups) Related guides * [FDA Medical Device RegulationComplete guide to FDA medical device regulation.](/guides/fda-medical-device-regulation) * [US Quality System RegulationComplete guide to US Quality System Regulation.](/guides/us-quality-system-regulation) * [US Medical Device RecallsComplete guide to US medical device recalls.](/guides/us-medical-device-recalls) * [US Post-Market SurveillanceComplete guide to US post-market surveillance requirements.](/guides/us-post-market-surveillance)