Article 51 designates a GPAI model as posing systemic risk when it has high-impact capabilities, presumed where the cumulative amount of computation used for training exceeds 10^25 FLOPs, or when so designated by the Commission. Article 55 then requires model evaluation, adversarial testing, tracking and reporting of serious incidents, and adequate cybersecurity protections at the model layer.

Why it matters

MedTech products rarely train models at this scale, but they frequently consume them. When a device relies on a designated systemic-risk GPAI, the manufacturer should map how upstream incident reporting and evaluation flow into the device's own post-market surveillance and vigilance obligations.

Common pitfalls

•Confusing systemic-risk designation (a property of the model) with high-risk status (a property of the AI system's use case).

Sources

Regulation (EU) 2024/1689, Articles 51 and 55 · EUR-Lex
RAPS Regulatory Focus · RAPS
FDA - Medical Devices · 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.