--- title: "Systemic Risk (GPAI), Definition | MedTech Terms" description: "Additional AI Act tier for GPAI models above a compute threshold or otherwise designated as posing systemic risk." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-systemic-risk#term", "name": "Systemic Risk (GPAI)", "description": "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. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Systemic Risk (GPAI) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Quality System](/ecosystems/quality-system) # Systemic Risk (GPAI) Additional AI Act tier for GPAI models above a compute threshold or otherwise designated as posing systemic risk. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 51 designates a [GPAI](/terms/ai-act-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](/terms/ai-act-gpai), the manufacturer should map how upstream incident reporting and evaluation flow into the device's own [post-market surveillance](/terms/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). ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory General-Purpose AI Model(GPAI) AI model trained on broad data at scale that displays significant generality and can be integrated into many downstream systems. ](/terms/ai-act-gpai)[ Regulatory High-Risk AI System (EU AI Act) AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III. ](/terms/ai-act-high-risk-system) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement 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. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [AI / ML in Devices](/ecosystems/ai-ml) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 RAPS· 1 FDA· 1 1. [1 Regulation (EU) 2024/1689, Articles 51 and 55 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1689/oj) 2. [2 RAPS Regulatory Focus Verified RAPS raps.org ](https://www.raps.org/news-and-articles/news-articles) 3. [3 FDA - Medical Devices Verified FDA fda.gov ](https://www.fda.gov/medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ai-act-systemic-risk) Learn in 60 seconds Card Lesson Quiz Additional AI Act tier for GPAI models above a compute threshold or otherwise designated as posing systemic risk. - · MedTech products rarely train models at this scale, but they frequently consume them. - · Article 55 then requires model evaluation, adversarial testing, tracking and reporting of serious incidents, and adequate cybersecurity protections at the model layer. Remember this Watch out: Confusing systemic-risk designation (a property of the model) with high-risk status (a property of the AI system's use case). Related terms - [General-Purpose AI Model(GPAI) ](/terms/ai-act-gpai) - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) You may also need Auto-suggested from Regulatory and shared keywords. - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) - [Genetic Testing Requirements (IVDR Article 4) ](/terms/ivdr-genetic-testing) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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