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.

Why it matters

Direct system-to-system integration with complaint-handling systems is now standard for high-volume reporters.

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.

Sources

21 CFR Part 803, Medical Device Reporting · FDA
EUDAMED Public Site · European Commission
MDCG Vigilance Guidance · MDCG

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.