GLOSSARY
High-risk AI System
Under the EU AI Act, an AI system whose intended use or context makes it high-risk under Annex III. High-risk systems carry conformity-assessment, documentation, oversight, and post-market monitoring obligations.
A high-risk AI system under the EU AI Act is one whose intended purpose appears in Annex III (eight high-risk areas including critical infrastructure, employment, essential services, and law enforcement) or that's a safety component of a regulated product. High-risk systems must satisfy Articles 9–15: risk management, data governance, technical documentation, record-keeping, transparency, human oversight, accuracy/robustness/cybersecurity, and conformity assessment before market placement.
Why it matters
For trade-AI specifically, systems used in customs risk-scoring, border management, or critical-infrastructure operations can be high-risk. That triggers the same compliance burden as a CE-marked medical device — a much heavier lift than a typical SaaS deployment, and a key reason explainability and model risk management need to be designed in from day one.
Related terms
- EU AI Act
- Conformity Assessment
- Human Oversight
- Annex III