MIRs use a harmonized template (initial, follow-up, final) capturing serious incident details, root cause, CAPA, and FSCA linkage. EUDAMED is the central submission channel. The MIR form is maintained by the European Commission and MDCG and is used for initial, follow-up, combined and final reports, including IMDRF adverse event terminology codes for the problem, investigation and component. Until the EUDAMED vigilance module is mandatory, reports are sent to national competent authorities, usually by email using the MIR XML or PDF form.

Why it matters

MIRs replaced legacy national-format reports; alignment with FDA MDR data fields helps run a single global vigilance database.

Common pitfalls

•A common pitfall is failing to submit an MIR within the mandated timelines, which are typically defined by the severity of the incident and can range from immediately to 15 days.
•Another mistake is submitting incomplete MIRs, leading to requests for additional information and delays in incident closure.
•Manufacturers sometimes neglect to properly investigate the root cause of an incident before submitting the MIR, resulting in inadequate corrective and preventive actions (CAPAs).

Sources

MDCG 2023-3 · MDCG
EUDAMED Public Site · European Commission
FDA MAUDE Database · FDA

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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.