--- title: "eMDR, Electronic Medical Device Reporting | MedTech Terms" description: "FDA's mandatory electronic submission system for Medical Device Reports. Plain-English Post-Market definition for MedTech teams, with examples and related terms" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/emdr#term", "name": "Electronic Medical Device Reporting", "alternateName": "eMDR", "description": "Since 2015, all manufacturer and importer MDRs must be submitted electronically via the FDA eMDR system using the FDA Form 3500A schema, either through the Electronic Submission Gateway or the Web Trader interface.", "url": "https://medtechterms.com/terms/emdr", "termCode": "emdr", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/emdr#article", "headline": "eMDR, Electronic Medical Device Reporting", "description": "FDA's mandatory electronic submission system for Medical Device Reports.", "url": "https://medtechterms.com/terms/emdr", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/emdr" }, "about": { "@id": "https://medtechterms.com/terms/emdr#term" }, "articleSection": "Post-Market", "inLanguage": "en", "keywords": "Electronic Medical Device Reporting, eMDR, Post-Market, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "FDA eMDR", "url": "https://www.fda.gov/industry/about-esg/electronic-medical-device-reporting-emdr", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "EUDAMED Public Site", "url": "https://ec.europa.eu/tools/eudamed/", "publisher": { "@type": "Organization", "name": "European Commission" } }, { "@type": "CreativeWork", "name": "MDCG Vigilance Guidance", "url": "https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en", "publisher": { "@type": "Organization", "name": "MDCG" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdr#term", "name": "EU Medical Device Regulation", "alternateName": "MDR", "url": "https://medtechterms.com/terms/mdr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/complaint-handling#term", "name": "Complaint Handling", "url": "https://medtechterms.com/terms/complaint-handling" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Post-Market", "item": "https://medtechterms.com/terms?cat=Post-Market" }, { "@type": "ListItem", "position": 4, "name": "Electronic Medical Device Reporting", "item": "https://medtechterms.com/terms/emdr" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/emdr#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary purpose of electronic Medical Device Reporting (eMDR)?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose of eMDR is to enable the FDA to monitor reports of adverse events and product problems associated with medical devices efficiently. 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This often involves descriptions of the event, its outcome, and any corrective actions taken." } }, { "@type": "Question", "name": "How does the eMDR system ensure data security and integrity?", "acceptedAnswer": { "@type": "Answer", "text": "The eMDR system utilizes secure electronic submission gateways, such as the Electronic Submission Gateway (ESG) or Web Trader, to ensure the confidentiality, integrity, and authenticity of the data submitted to the FDA." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Electronic Medical Device Reporting [All terms](/terms) Post-Market [Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)eMDR # Electronic Medical Device Reporting FDA's mandatory electronic submission system for Medical Device Reports. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Since 2015, all manufacturer and importer MDRs must be submitted electronically via the FDA eMDR system using the FDA Form 3500A schema, either through the Electronic Submission Gateway or the Web Trader interface. What the regulation says The FDA mandates electronic submission of Medical Device Reports (MDRs) for manufacturers and importers since 2015, as outlined in 21 CFR Part 803. This regulation requires using the FDA eMDR system and the FDA Form 3500A schema for all submissions. ## What this means in practice Direct system-to-system integration with complaint-handling systems is now standard for high-volume reporters. ## Examples - A medical device manufacturer submits an eMDR for a reported malfunction of a surgical robot that resulted in patient injury. - An importer of diagnostic test kits submits an eMDR after receiving complaints about false-positive results impacting patient care. - A quality assurance professional uses the FDA Form 3500A schema to categorize an adverse event before its electronic submission. Common pitfalls - • Failing to submit MDRs electronically can lead to non-compliance with FDA regulations. - • Incorrectly coding or categorizing adverse events within the eMDR system can result in data quality issues and regulatory scrutiny. - • Not integrating eMDR submission with internal complaint handling systems can create inefficiencies and increase the risk of missed reporting deadlines. - • Assuming that all adverse events are reportable as MDRs without proper evaluation can lead to unnecessary submissions and resource drain. ## Frequently asked questions What is the primary purpose of electronic Medical Device Reporting (eMDR)? The primary purpose of eMDR is to enable the FDA to monitor reports of adverse events and product problems associated with medical devices efficiently. This helps the FDA identify potential safety issues, assess risks, and take appropriate actions to protect public health. Which entities are required to submit eMDRs? What information is typically included in an eMDR submission? How does the eMDR system ensure data security and integrity? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling)[ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr) ### 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)[ Post-Market Customer Notification Letter Communication to users notifying them of a safety issue, corrective action, or important product information. ](/terms/customer-notification)[ Post-Market FDA Recall Classifications I, II, III FDA's risk-based grading of recalls based on potential for harm. ](/terms/recall-classifications) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 European Commission· 1 MDCG· 1 1. [1 FDA eMDR Verified FDA · fda.gov ](https://www.fda.gov/industry/about-esg/electronic-medical-device-reporting-emdr) 2. [2 EUDAMED Public Site Verified European Commission · ec.europa.eu ](https://ec.europa.eu/tools/eudamed/) 3. [3 MDCG Vigilance Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) 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 eMDR Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=emdr) Learn in 60 seconds Card Lesson Quiz FDA's mandatory electronic submission system for Medical Device Reports. - · Direct system-to-system integration with complaint-handling systems is now standard for high-volume reporters. Remember this Watch out: Failing to submit MDRs electronically can lead to non-compliance with FDA regulations. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [Complaint Handling ](/terms/complaint-handling) You may also need Auto-suggested from Post-Market and shared keywords. - [Manufacturer Incident Report(MIR) ](/terms/mir) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [5-Day Report ](/terms/five-day-report) - [Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting) - [Removal vs Correction (21 CFR 806) ](/terms/removal-vs-correction) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) [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. 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