AI Risk Assessment ToolEU AI Act high-risk AI in regulated products (Annex I)
AI that is a safety component of a product already covered by EU product-safety law (machinery, medical devices, toys and others) is high-risk under Annex I.
Screening questions
- Is the AI a safety component of, or itself, a product covered by EU product legislation that needs third-party conformity assessment (e.g. machinery, medical devices, toys, lifts, radio equipment, vehicles)?
If this applies
AI in a product covered by EU product-safety law. High-risk obligations for these apply from 2 August 2028 (moved from 2 August 2027 by the Digital Omnibus).
Screen your AI system free (24 questions)
The AI Governance Toolkit Professional ($599) has the EU AI Act risk assessment workbook for each system, plus the AI policy and risk register, ISO/IEC 42001 gap assessment and NIST AI RMF mapping.
Other parts of the EU AI Act
- prohibited AI practices (Article 5)
- high-risk AI systems (Annex III)
- transparency obligations (Article 50)
- general-purpose AI (GPAI) models
- Timeline: when each obligation applies
EU AI Act (Regulation (EU) 2024/1689) as amended by the Digital Omnibus on AI (in force 27 July 2026). Screening questions are our own summary, not legal text. This is a screening aid, not legal advice.