High-risk classification triggers the most demanding set of obligations in the EU AI Act. Use this guide to self-assess whether your system falls within Annex III or the Article 6(1) product safety track.
Article 99 penalty for high-risk AI providers and deployers
Placing a high-risk AI system on the market without meeting Articles 9–17 obligations, without conformity assessment, or without EU database registration carries a penalty of up to €30,000,000 or 6% of global annual turnover, whichever is higher. Compliance is mandatory from 2 August 2026.
Not sure which track applies to your AI system?
Describe what your system does and Regumatrix checks it against Article 6, Annex III, and the full regulation — in about 30 seconds. Your first 3 analyses are free.
Check my AI system — 3 free analyses includedAI systems that are safety components of products already covered by EU harmonisation legislation (e.g. Machinery Regulation, Medical Device Regulation, Aviation safety rules) are automatically high-risk and must undergo the conformity assessment required by that sectoral legislation.
AI systems listed in any of the 8 domains in Annex III are high-risk unless an exemption under Article 6(3) applies. All three conditions below must be met:
Read the full list at Annex III and the classification rules at Article 6.
Even if your system falls in an Annex III domain, it may be exempt if: it performs a narrow procedural task, does not influence human decisions, detects patterns in existing data for human review only, or is intended for preparatory tasks only. Document your exemption reasoning carefully.
Many teams correctly identify that their AI falls within an Annex III domain, but then assume it is exempt under Article 6(3). These exemptions are narrow and must be formally documented. Check if any of these apply to your system:
High-risk classification is not just a label — it triggers risk management, technical documentation, logging, human oversight, conformity assessment, CE marking, and EU database registration. Getting the classification wrong in either direction is a problem.
Describe your AI system in plain language. Regumatrix checks it against every article of the EU AI Act and returns your risk tier, Annex classification, the exact obligations that apply, and your fine exposure under Article 99. Eight sections. About 30 seconds.
8-section report · Article citations · ~30 seconds · No credit card
