FDA Medical Device Reporting: MDR Requirements & Timelines
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If you manufacture or distribute medical devices in the US, you are legally required to comply with FDA Medical Device Reporting (MDR) under 21 CFR Part 803 (Subpart E) regardless of your device classification. FDA MDR activities include monitoring, identifying, and reporting serious device-related adverse events within strict timelines and documenting everything in your MDR files. Failure to fulfill FDA MDR obligations can expose your company to FDA warning letters, recalls, even enforcement, not to mention patient risk.
Video guide
FDA MDR: Medical Device Reporting
An overview of 21 CFR 803, medical device reporting deadlines, five-day reports and electronic MDR submissions.
Open video pageTranscript (English)
When must you file an FDA MDR? Under 21 CFR 803, manufacturers report deaths, serious injuries and certain malfunctions linked to their devices. And the clock starts early. For manufacturers, the deadline is 30 calendar days from the day any employee becomes aware. It drops to 5 work days when an event needs remedial action to prevent an unreasonable risk of substantial harm to public health, or when FDA asks in writing. You are not the only reporter. User facilities, such as hospitals, report deaths and serious injuries within 10 work days. Importers have 30 calendar days. And you must fill in what their reports leave out. And for you, there is no paper route. Since August 14, 2015, manufacturers and importers must submit every initial and supplemental MDR electronically, in a format FDA can process, review and archive. Start with three things. One: screen every complaint for reportability. Two: write MDR procedures for evaluating and filing. Three: keep event files for the device's expected life, at least 2 years. Once aware, the clock is running. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.
FDA Medical Device Reporting: reportability comes first
Medical Device Reporting (MDR) under 21 CFR Part 803 is the US FDA adverse-event reporting framework. It is different from the EU Medical Device Regulation, which uses the same acronym. A report does not establish that a device caused the event; it communicates the available information under the applicable reporting criteria.
Manufacturers assess whether information reasonably suggests their device may have caused or contributed to a death or serious injury, or malfunctioned in a way likely to cause or contribute to death or serious injury if it recurred. Do not replace that malfunction threshold with “any harm.” Investigate complaints promptly and document both reportable and nonreportable decisions.
Reporting deadlines and recipients
| Reporter and event | Deadline framework | Recipient |
|---|---|---|
| Manufacturer: death, serious injury or qualifying malfunction | Generally 30 calendar days after awareness | FDA |
| Manufacturer: event requiring remedial action to prevent an unreasonable risk of substantial harm to public health, or an FDA-requested 5-day report | 5 work days under the applicable awareness rule | FDA |
| Initial importer: death or serious injury | Generally 30 calendar days | FDA and manufacturer |
| Initial importer: qualifying malfunction | Generally 30 calendar days | Manufacturer |
| User facility: reportable death | Generally 10 work days | FDA and manufacturer, if known |
| User facility: reportable serious injury | Generally 10 work days | Manufacturer, or FDA if manufacturer is unknown |
Apply the definitions and exceptions in Part 803 and FDA’s manufacturer guidance. A reportability decision, complaint investigation and urgent corrective action can run in parallel; waiting for a complete investigation does not suspend a reporting deadline.
A practical complaint-to-report workflow
- Capture the earliest awareness date and the people receiving the information, including distributors and service teams.
- Identify the device, lot/serial number, software version, patient outcome, event narrative and available follow-up contacts.
- Evaluate reportability using the relevant regulatory definitions, prior similar events and available clinical/technical information. Record the rationale.
- Escalate potential 5-day events immediately. Assess corrections/removals and recall obligations separately; an MDR alone does not complete those actions.
- Submit the report on time using the applicable FDA process, identifying missing information and efforts to obtain it.
- Monitor follow-up information, submit required supplements and connect the investigation to CAPA, risk management and any field action.
Electronic submission and records
Manufacturers and importers generally submit individual reports electronically unless FDA grants an exemption. The eMDR program explains the supported electronic submission arrangements. Establish technical access and test the process before a real deadline. Retain acknowledgments and resolve rejected transmissions rather than treating “sent” as proof of successful receipt.
Part 803.17 addresses written MDR procedures; Part 803.18 addresses records. Maintain event files, awareness dates, reportability decisions, investigation evidence, submissions, acknowledgments and links to complaint/CAPA records. Supplemental manufacturer reports are generally due within one month after receiving qualifying additional information under Part 803.56, rather than an unqualified “30 days for every update.”
QMSR and postmarket controls
QMSR took effect on February 2, 2026. It does not replace Part 803. Align supplier, distributor and US Agent agreements so safety information reaches the actual reporting owner quickly. The agent role alone does not include MDR reporting.
Summary reporting, including VMSR, applies only when its specific eligibility and conditions are satisfied. Deaths and serious injuries must not be hidden in a malfunction summary. Pure Global can assess procedures, train escalation teams and support report preparation while preserving the manufacturer’s accountability.
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Frequently asked questions
No. Assess whether recurrence would be likely to cause or contribute to death or serious injury under Part 803. Document the rationale and investigation, and revisit it when new information changes the assessment.
A reporting deadline is not suspended while the investigation continues. Submit the available required information, describe what is missing and follow up with a supplemental report when the regulatory conditions apply.
No. QMSR has been effective since February 2, 2026, while Part 803 continues to apply separately. Complaint handling, risk management, MDR decisions and corrective actions must work together.
No. VMSR has product-code eligibility and other conditions. Death and serious-injury events are not converted into routine malfunction summaries; assess the individual reporting and program requirements first.
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