Electronic Medical Device Reporting
FDA's mandatory electronic submission system for Medical Device Reports.
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. Submitters can use the Electronic Submissions Gateway with HL7 ICSR XML files, which suits high-volume reporters, or the eSubmitter tool for lower volumes. Each submission gets acknowledgments confirming receipt and successful processing, and these should be kept as proof of filing. User facilities may still report on paper.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.
- •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
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsMore in Post-Market
· Same categoryExpedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
Communication to users notifying them of a safety issue, corrective action, or important product information.
FDA's risk-based grading of recalls based on potential for harm.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 121 CFR Part 803, Medical Device ReportingTier 1 VerifiedFDAecfr.gov
- 2EUDAMED Public SiteTier 2 VerifiedEuropean Commissionec.europa.eu
- 3MDCG Vigilance GuidanceTier 2 VerifiedMDCGhealth.ec.europa.eu
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