Regulation (EU) 2024/1689
Binding law across the EU. Risk-tiered: prohibits unacceptable uses, imposes heavy obligations on high-risk AI, transparency duties on limited-risk, and special rules for general-purpose AI models. Fines up to €35M / 7% turnover.
Read EU AI Act as a step-by-step path
Chap I - General
Scope, definitions and the cross-cutting AI literacy duty (Art.4) that applies to every provider and deployer.
- 1Confirm whether the regulation applies to you (provider, deployer, importer, distributor).
- 2Implement AI literacy across staff dealing with AI.
Cl.7.2/7.3 cover competence and awareness.
GOVERN 3 covers workforce.
Chap II - Prohibited
A short list of AI uses that are simply banned. The hard floor of the regime.
- 1Screen every use case against Article 5 before design.
- 2Document the screen and keep evidence.
No direct equivalent - ISO will not stop you doing something unethical that is technically conformant.
GOVERN 1 captures legal obligations; the rest is left to the organisation.
Chap III - High-risk classification
The core of the Act. Classification (Art.6 + Annex III), then a stack of obligations: risk management, data, documentation, logs, transparency, oversight, accuracy.
- 1Classify the system against Annex III and Art.6.
- 2Run a risk-management system continuously (Art.9).
- 3Meet data-governance duties (Art.10).
- 4Produce technical documentation (Art.11 + Annex IV).
- 5Build in logging (Art.12), transparency (Art.13), oversight (Art.14).
- 6Demonstrate accuracy, robustness, cybersecurity (Art.15).
- 7Operate a QMS (Art.17).
- 8Pass conformity assessment and register (Art.43/49).
- 9Deployers: oversight + FRIA where required (Art.26/27).
ISO 42001 + Annex A gives you most of the management-system evidence: Cl.6 → Art.9; Cl.7.5 → Art.11; A.7 → Art.10; A.6.2.4 → Art.15; A.8/A.9 → Art.13/14.
MAP/MEASURE/MANAGE cycle satisfies most of the substantive content but NIST will not produce a conformity dossier on its own.
Chap III §2 - High-risk requirements
Chap III §3 - Providers
Chap III §3 - Supply chain
Chap III §3 - Deployers
Chap IV - Transparency
Limited-risk obligations: tell people they are interacting with AI and label AI-generated content.
- 1Add user-facing notice for chatbots and similar systems.
- 2Label deepfakes and synthetic media.
Annex A.8.
MEASURE 2.8 (explainability) + MANAGE 2.3.
Chap V - GPAI
General-purpose AI models have their own duties - documentation, downstream info, copyright policy, and stricter rules for systemic-risk models.
- 1Determine if you're a GPAI provider; if yes, prepare the Art.53 info pack.
- 2Assess whether your model has systemic risk (Art.51).
- 3If systemic: model evaluations, mitigation, incident reporting, cybersecurity (Art.55).
Annex A.10 + 7.5 cover the supplier and documentation angle.
GOVERN 6 + MAP 4.
Chap IX - Post-market
Once on the market, you keep watching the system and report serious incidents.
- 1Operate a post-market monitoring plan (Art.72).
- 2Report serious incidents to authorities within the statutory window (Art.73).
Cl.9.1 + 10.2 + Annex A.6.2.8.
MANAGE 4.
Chap XII - Penalties
The enforcement teeth: up to €35M or 7% of worldwide turnover for prohibited practices.
- 1Treat penalty exposure as a board-level risk; map every prohibited / high-risk obligation to an owner.
No equivalent - ISO 42001 is voluntary.
No equivalent - NIST AI RMF is voluntary.