--- title: "MDR, Medical Device Reporting (FDA) | MedTech Terms" description: "FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Medical Device Reporting (FDA) [All terms](/terms) Post-Market [Regulated Pathways](/ecosystems/regulated-pathways)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)MDR # Medical Device Reporting (FDA) FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Medical Device Reporting under 21 CFR Part 803 requires manufacturers, importers, and device user facilities to report device-related deaths, serious injuries, and certain malfunctions to FDA within defined timeframes. What the regulation says Under 21 CFR Part 803, manufacturers, importers, and device user facilities have specific obligations to report adverse events related to medical devices to the FDA. These reports include deaths, serious injuries, and certain malfunctions, each with defined reporting timeframes and submission requirements, ensuring [post-market surveillance](/terms/post-market-surveillance). ## What this means in practice Not to be confused with the [EU Medical Device Regulation](/terms/mdr). FDA MDR data is publicly searchable through the MAUDE database. ## Examples - A hospital, as a user facility, reports a patient death potentially caused by a ventilator malfunction to the FDA within 10 working days, as required by 21 CFR 803.30. - A manufacturer submits a 5-day report to the FDA after discovering a serious injury associated with one of their surgical devices that required immediate remedial action to prevent further harm, per 21 CFR 803.53. - An importer identifies a pattern of malfunctions in an imaging device that could lead to serious injury and submits an MDR to the FDA within 30 calendar days, adhering to 21 CFR 803.40. Common pitfalls - • Failing to distinguish between reportable malfunctions and those that do not meet the criteria for Medical Device Reporting can lead to non-compliance. - • Delaying the submission of a report due to incomplete information, rather than submitting a timely initial report with a follow-up, is a common pitfall. - • Not adequately training personnel on the criteria and procedures for identifying and reporting adverse events can result in missed reports. - • Confusing the reporting requirements for manufacturers with those for user facilities or importers can lead to incorrect submissions. - • Underreporting subtle device malfunctions that, if recurrent, could escalate to serious harm is a significant oversight. ## Frequently asked questions What is the primary purpose of Medical Device Reporting? The primary purpose is to enable the FDA to monitor device performance, detect potential safety issues, and take appropriate actions to protect public health. Who is required to submit Medical Device Reports? What types of events must be reported? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ Adverse Event(AE) ](/terms/adverse-event) ### See also Closely related context worth reading. - [ Medical Device Vigilance ](/terms/vigilance) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. ](/terms/vigilance)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance) ### Post-Market Mastery · From this learning path [ Post-Market Medical Device Recall Removal or correction of a marketed device that violates FDA law. Adjacent lesson ](/terms/recall?from=post-market-mastery)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. Adjacent lesson ](/terms/complaint-handling?from=post-market-mastery)[ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca?from=post-market-mastery)[ Post-Market Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. ](/terms/psur?from=post-market-mastery) ### More in Post-Market · Same category [ Post-Market 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report)[ Post-Market Annual Report (PMA) Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. ](/terms/annual-report-pma) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Post-Market Mastery](/paths/post-market-mastery)Lesson 6 of 9 Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Mentioned in recent activity 1 entry PubMed (1) [Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. ](https://pubmed.ncbi.nlm.nih.gov/41915013/) Clinical orthopaedics and related research · 2026-06-01 ## Latest in MedTech [View all](/latest?term=mdr-reporting) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - PubMed 2026-06-01 [Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. ](https://pubmed.ncbi.nlm.nih.gov/41915013/) Clinical orthopaedics and related research ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 FDA· 2 1. [1 21 CFR Part 803 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803) 2. [2 MAUDE Database Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) 3. [3 FDA Recalls - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Post-Market Acronym MDR Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=mdr-reporting) Learn in 60 seconds Card Lesson Quiz FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. - · Not to be confused with the EU Medical Device Regulation. - · FDA MDR data is publicly searchable through the MAUDE database. Remember this Watch out: Failing to distinguish between reportable malfunctions and those that do not meet the criteria for Medical Device Reporting can lead to non-compliance. Related terms - [Medical Device Vigilance ](/terms/vigilance) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) You may also need Auto-suggested from Post-Market and shared keywords. - [Annual Report (PMA) ](/terms/annual-report-pma) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Removal vs Correction (21 CFR 806) ](/terms/removal-vs-correction) - [Field Action vs Recall ](/terms/field-action-vs-recall) - [Section 522 Postmarket Surveillance(Section 522) ](/terms/section-522) - [Trend Reporting (MDR/MIR) ](/terms/trend-reporting) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)