EU AI Act guides for European SMEs
Guides and analysis to help European SMEs navigate EU AI Act compliance.
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The EU AI Act for healthcare and medical AI: the two high-risk routes
AI in healthcare is high-risk by two routes: as a medical device (Annex I / MDR) or a listed health use case (Annex III). How each works.
Read articleEU AI Act conformity assessment and CE marking: a provider's guide
High-risk AI needs a conformity assessment, an EU declaration and CE marking. Most Annex III systems self-assess — here is the process.
Read articleEU AI Act & biometrics: what's banned vs high-risk
The EU AI Act splits biometric AI in two: prohibited uses under Article 5, high-risk uses under Annex III point 1. A plain-English map.
Read articleThe EU AI Act for insurers: life & health risk pricing
Why AI risk pricing for life and health insurance is high-risk under Annex III point 5(c), and what insurers must do about it.
Read articleThe EU AI Act for education & edtech
Why admissions, grading and exam proctoring are high-risk under Annex III point 3, what is prohibited, and what schools and edtech must do.
Read articleThe EU AI Act for HR & recruitment teams
Why AI recruiting tools are high-risk under Annex III point 4, what deployers and providers must do, and the 2 December 2027 deadline.
Read articleThe EU AI Act for fintech & credit scoring
Why AI credit scoring is high-risk under Annex III point 5(b), the fraud-detection carve-out, and what lenders and fintechs must do.
Read articleEU AI Act Annex IV: the technical documentation file explained (2026)
What Annex IV technical documentation must contain under Article 11: the nine sections, the simplified SME route, and the 10-year retention rule.
Read articleEU AI Act high-risk systems explained (Annex III)
What makes an AI system high-risk under the EU AI Act — the Annex III categories, the Annex I product route, the obligations, and the 2027–2028 deadlines.
Read articleThe Digital Omnibus on AI: what actually changed, and what did not
The Digital Omnibus on AI postpones high-risk obligations to 2 December 2027 (Annex III) and 2 August 2028 (Annex I). What SMEs should do now.
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