Medical Device Reporting (MDR)
FDA’s Medical Device Reporting regulation — the mandatory post-market reporting system for device-related deaths, serious injuries, and malfunctions. Manufacturers, importers, and device user facilities must report qualifying events to FDA within defined timeframes, feeding the MAUDE database that surfaces device safety signals.
What this does not cover
stated in the document's own scope- Covers post-market adverse-event reporting for devices, not the quality-system controls that produce and investigate the underlying events — those are in 21 CFR Part 820.
- Applies to medical devices; adverse-experience reporting for drugs is governed by 21 CFR §314.80 and for biologics by §600.80.
- Addresses individual reportable events, not device corrections and removals (recalls), which are reported under the separate 21 CFR Part 806.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 803 is FDA’s Medical Device Reporting (MDR) regulation — the mandatory post-market system for reporting device-related deaths, serious injuries, and certain malfunctions. It sets who must report (manufacturers, importers, and device user facilities), what events qualify, the timeframes for submission, and the content and format of the reports, which are submitted electronically. Manufacturer reports feed the MAUDE database that FDA uses to surface device safety signals. The regulation defines the key terms — such as serious injury and malfunction — that determine when an event becomes reportable and who carries the duty to report it.
Scope & applicability
Post-market adverse-event reporting for medical devices by manufacturers, importers, and user facilities in the US market.
Legal basis & how it acquires force
Part 803 is a binding regulation in Title 21 CFR, issued under the Federal Food, Drug, and Cosmetic Act — principally §519, which authorises FDA to require records and reports on devices necessary to protect public health. Reporting is a legal obligation for the parties the rule covers, with defined timeframes: manufacturers generally report qualifying events within 30 calendar days, and within 5 working days for events requiring remedial action to prevent an unreasonable risk of substantial harm; user facilities report device-related deaths to FDA and the manufacturer, and serious injuries to the manufacturer, within 10 working days.
Document structure
| Part | Covers |
|---|---|
| Subpart A | General provisions — purpose, scope, definitions (serious injury, malfunction, MDR reportable event), and electronic-reporting requirements |
| Subpart B | Generally applicable requirements for individual adverse-event reports (§§803.20–803.23) — how to complete and submit a report, reporting codes, exemptions, and the electronic MDR format |
| Subpart C | User facility reporting requirements — what hospitals and other user facilities must report and their timeframes |
| Subpart D | Importer reporting requirements — the reports an importer of devices must submit to FDA and the manufacturer |
| Subpart E | Manufacturer reporting requirements — individual adverse-event reports, timeframes, and supplemental reports |
Key requirements
- Determine reportability for deaths, serious injuries, and malfunctions
- Submit reports within the required 30-day and 5-day timeframes
- Link complaint handling to MDR reportability decisions
- Maintain MDR event files and decision records
Implementation tips
- Document the reportability decision — a defensible "not reportable" rationale is inspection-critical
- Integrate Part 803 with your 820.198 complaint system so nothing falls through
- Trend your own MAUDE entries; regulators and customers read them
Revision notes
Long-standing regulation; eMDR electronic submission became mandatory in 2015. Complements the shift to 21 CFR 820 harmonization under the QMSR (effective 2026).
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 803 is the US device-vigilance counterpart to the EU’s incident-reporting and vigilance requirements under the Medical Devices Regulation (EU) 2017/745, and the two form the device analogue to pharmacovigilance reporting for drugs. It sits alongside the quality-system requirement at 21 CFR Part 820 (which includes complaint handling and CAPA that often generate MDR reports) and the correction-and-removal reporting of 21 CFR Part 806, together making up the US post-market device-safety framework.
21 CFR Part 803: frequently asked questions
Quick answers to common questions about 21 CFR Part 803.
Who must report under 21 CFR Part 803?
Device manufacturers, importers, and device user facilities. Each has distinct duties: manufacturers and importers report to FDA, and user facilities report device-related deaths to FDA and the manufacturer and serious injuries to the manufacturer.
What are the MDR reporting timeframes?
Manufacturers generally report qualifying events within 30 calendar days, and within 5 working days when remedial action is needed to prevent unreasonable risk of substantial harm. User facilities report within 10 working days.
What is the MAUDE database?
MAUDE (Manufacturer and User Facility Device Experience) is the FDA database populated by Part 803 reports. It holds device-related adverse-event reports and is used to identify device safety signals.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.