EU Artificial Intelligence Act Compliance Checklist 2026
The EU AI Act classifies AI systems by risk level and imposes obligations on providers and users. High-risk AI systems require conformity assessments, documentation, and human oversight. Limited-risk …
Maximum penalty: €35,000,000 or 7% of global annual turnover
Enforcement: August 2, 2026
Complete each item below to achieve compliance. Use ComplianceIQ to generate all required documentation automatically.
Regulatory Requirements
1. AI Risk Classification
Classify each AI system you use or deploy as Minimal, Limited, High, or Unacceptable risk under EU AI Act Annex III.
Due: August 2, 2026
2. Transparency Disclosures
Inform users when they are interacting with AI (chatbots, generated content, AI-assisted decisions).
Due: August 2, 2026
3. AI Acceptable Use Policy
Document how employees may and may not use AI tools within your organization.
Due: August 2, 2026
4. Employee AI Monitoring Notice
Notify employees if AI systems are used to monitor their work performance or productivity.
Due: August 2, 2026
5. Human Oversight Procedures
Implement procedures ensuring human review of high-risk AI decisions.
Due: August 2, 2026
Implementation Steps
6. Classify all AI-assisted clinical tools under EU AI Act Annex III (most are high-risk)
7. Ensure AI diagnostic tools have CE marking if used in EU
8. Document training data sources, accuracy metrics, and known limitations for each AI tool
9. Implement human oversight for all AI diagnostic or treatment recommendations
10. Train clinical staff on AI tool limitations and override procedures
11. Maintain audit trails for AI-assisted clinical decisions
12. Review FDA AI/ML-based Software as a Medical Device (SaMD) guidance if US-based
13. Conduct bias testing across patient demographic groups
14. Establish procedures for AI-related adverse events