All terms
Electronic Medical Device Reporting
FDA's mandatory electronic submission system for Medical Device Reports.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast 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
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.
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5-Day Report
Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
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Annual Report (PMA)
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
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Customer Notification Letter
Communication to users notifying them of a safety issue, corrective action, or important product information.
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FDA Recall Classifications I, II, III
FDA's risk-based grading of recalls based on potential for harm.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
FDA·1European Commission·1MDCG·1
- 1
FDA eMDRVerifiedFDAfda.gov
- 2
EUDAMED Public SiteVerifiedEuropean Commissionec.europa.eu
- 3
MDCG Vigilance GuidanceVerifiedMDCGhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.