EU AI Act Article 6: Is Your AI System High-Risk?

Understanding High-Risk Classification

Article 6 defines two paths to high-risk classification. First, AI systems that are safety components of products covered by EU harmonisation legislation (medical devices, machinery, toys, etc.). Second, AI systems listed in Annex III — which covers areas like biometric identification, critical infrastructure, employment, credit scoring, and law enforcement.

The key question for most businesses: does your AI tool make or significantly influence decisions about people? If it helps you write emails, summarise documents, or generate marketing content, it is almost certainly not high-risk.

The 2-Minute High-Risk Check

Answer these questions about each AI tool you use: (1) Does it make decisions about hiring, firing, or promotion? (2) Does it assess creditworthiness or insurance eligibility? (3) Does it process biometric data for identification? (4) Does it affect access to essential services like education or healthcare? (5) Is it embedded in a regulated product like a medical device?

If you answered no to all five, your AI system is very likely not high-risk. Document this assessment and move on to your general AI literacy obligations under Article 4.

What High-Risk Classification Means

If your AI is high-risk, you face substantial compliance obligations: risk management systems, data governance, technical documentation, record-keeping, transparency, human oversight, accuracy and robustness requirements. These obligations apply from 2 August 2026.

The compliance cost is significant — estimated at 6,000 to 7,000 euros per high-risk AI system for initial conformity assessment, plus ongoing monitoring costs. This is why accurate classification matters: you do not want to over-classify and waste resources, or under-classify and face penalties.

This article is for informational purposes only and does not constitute legal advice. Regulatory requirements change frequently — verify current rules with official sources. Built by Sawai Gyoseishoshi Office, Hiroshima, Japan.