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.
Post-market adverse-event reporting for medical devices by manufacturers, importers, and user facilities in the US market.
- 01Determine reportability for deaths, serious injuries, and malfunctions
- 02Submit reports within the required 30-day and 5-day timeframes
- 03Link complaint handling to MDR reportability decisions
- 04Maintain MDR event files and decision records
Long-standing regulation; eMDR electronic submission became mandatory in 2015. Complements the shift to 21 CFR 820 harmonization under the QMSR (effective 2026).
21 CFR Part 803: frequently asked questions
Quick answers to common questions about 21 CFR Part 803.
What is 21 CFR Part 803?
21 CFR Part 803 — Medical Device Reporting (MDR) — is a regulation issued by the Food and Drug Administration (United States). 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.
Who does 21 CFR Part 803 apply to?
Post-market adverse-event reporting for medical devices by manufacturers, importers, and user facilities in the US market.
What are the key requirements of 21 CFR Part 803?
FDA 21 CFR Part 803 requires, among other things: 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.
When was 21 CFR Part 803 last updated?
The current version of 21 CFR Part 803 dates from April 2022. Long-standing regulation; eMDR electronic submission became mandatory in 2015. Complements the shift to 21 CFR 820 harmonization under the QMSR (effective 2026).
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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When 21 CFR Part 803 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.