Systemic Risk (GPAI)
Additional AI Act tier for GPAI models above a compute threshold or otherwise designated as posing systemic risk.
Definition
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.What this means in practice
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.- •Confusing systemic-risk designation (a property of the model) with high-risk status (a property of the AI system's use case).
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsAI model trained on broad data at scale that displays significant generality and can be integrated into many downstream systems.
AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2024/1689, Articles 51 and 55VerifiedEUR-Lexeur-lex.europa.eu
- 2
RAPS Regulatory FocusVerifiedRAPSraps.org
- 3
FDA - Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.