High-Risk AI System Compliance Checklist
A step-by-step checklist for organisations operating high-risk AI systems under Annex III of the EU AI Act, covering all mandatory requirements before market placement.
Quick Answer
High-risk AI systems under the EU AI Act require a quality management system, Annex IV technical documentation, risk management, human oversight, and CE marking before EU market placement.
Compliance Checklist (8 items)
Penalty if not compliant
Up to €30 million or 6% of global annual turnover, whichever is higher (Article 99).
Frequently Asked Questions
What makes an AI system "high-risk" under the EU AI Act?
An AI system is high-risk if it falls within Annex III categories — including AI used in critical infrastructure, education, employment, essential services, law enforcement, migration, or justice — or is a safety component of a product covered by existing EU product safety legislation.
Can I self-assess a high-risk AI system or do I need a notified body?
For most Annex III systems, providers may conduct a self-assessment. A notified body is mandatory only when the system is also subject to third-party conformity assessment under other EU harmonised legislation (e.g., medical devices, machinery).
When do high-risk AI Act obligations take effect?
For general-purpose AI and prohibited practices: August 2025. For high-risk AI systems in Annex III: August 2026. For high-risk AI embedded in regulated products: August 2027.
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