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AIGP Quest

Law and framework guide

EU AI Act

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The EU AI Act (Regulation (EU) 2024/1689) regulates AI by risk. It bans some practices, sets strict rules for high-risk systems, requires transparency for others and leaves most AI alone. It covers providers, deployers, importers and distributors, including non-EU firms whose AI output is used in the EU. In force since 1 August 2024, it applies in stages to 2 August 2028, as amended by the 2026 Digital Omnibus.

In short

  • Risk attaches to the intended use, not the technology: prohibited (Art. 5), high-risk (Art. 6, Annexes I and III), transparency (Art. 50), minimal.
  • Bans and AI literacy have applied since 2 Feb 2025, GPAI rules since 2 Aug 2025 and Art. 50 transparency since 2 Aug 2026.
  • The Digital Omnibus (Regulation (EU) 2026/1744) moved Annex III high-risk duties to 2 Dec 2027 and Annex I duties to 2 Aug 2028.
  • Fines reach €35 million or 7% of worldwide turnover for prohibited practices. SMEs and start-ups pay the lower of the two amounts.
Key facts
Official nameRegulation (EU) 2024/1689, the Artificial Intelligence Act
In force1 August 2024
Latest amendmentRegulation (EU) 2026/1744 (Digital Omnibus on AI), in force 27 July 2026
Applies toProviders, deployers, importers, distributors and authorized representatives, inside or outside the EU
High-risk duties applyAnnex III from 2 Dec 2027; Annex I from 2 Aug 2028
Maximum fine€35 million or 7% of worldwide annual turnover, whichever is higher
Enforced byNational market surveillance authorities; the European Commission's AI Office for GPAI models

What is the EU AI Act?

The EU AI Act is Regulation (EU) 2024/1689, the EU's horizontal law on artificial intelligence. It entered into force on 1 August 2024 and applies directly in all 27 Member States.

It borrows from EU product-safety law, with conformity checks and CE marking, and adds the protection of fundamental rights such as privacy and equality.

Risk attaches to the intended use, not the technology. The same face-analysis model can be banned in one setting, high-risk in another and lightly regulated in a third. Our lesson on the risk pyramid walks through the logic.

Who does the EU AI Act apply to?

The Act places duties on "operators" along the AI value chain (Art. 3). Duties follow what you do with a system, not what your contract says.

RoleWho it isTypical duties
ProviderDevelops an AI system or GPAI model, or has one developed, and places it on the market or puts it into service under its own nameThe heaviest: requirements, conformity assessment, monitoring
DeployerUses an AI system under its own authority in a professional contextUse as instructed, human oversight, logs, notices
ImporterAn EU-based entity placing a non-EU provider's system on the EU marketVerify conformity before placing it on the market
DistributorAnyone else making a system available in the supply chainCheck the CE marking, declaration and instructions
Authorized representativeAn EU-based entity with a written mandate from a non-EU providerAct as the provider's contact point in the EU

Scope is extraterritorial under Art. 2. It covers providers placing AI on the EU market wherever they are based. It also covers non-EU providers and deployers whose AI output is used in the EU.

Key exclusions: AI used only for military, defense or national security; AI developed only for scientific research; and purely personal, non-professional use.

Roles can flip under Art. 25. A deployer or distributor becomes the provider of a high-risk system if it rebrands it, substantially modifies it, or repurposes it into high-risk. See provider vs deployer for worked examples.

How does the risk-based approach work?

The Act sorts AI uses into four tiers, plus a separate track for general-purpose AI models.

TierLegal basisExamplesWhat applies
ProhibitedArt. 5Social scoring, harmful manipulation, untargeted facial-image scraping, emotion recognition at work or schoolBanned outright
High-riskArt. 6 with Annex I or Annex IIIAI safety components in medical devices or machinery; hiring, credit scoring, education, essential public servicesStrict requirements before and after launch
TransparencyArt. 50Chatbots, AI-generated or manipulated content, deepfakesDisclosure and machine-readable marking
MinimalNo specific rulesSpam filters, AI in video gamesNo new duties beyond AI literacy (Art. 4)

There are two doors into high-risk. Door one is Art. 6(1): AI that is a safety component of a product, or is itself a product, under Annex I product laws. The product must also need third-party conformity assessment. Door two is Art. 6(2): AI used in one of the eight Annex III areas.

Those areas are biometrics, critical infrastructure, education, employment, access to essential services, law enforcement, migration and border control, and justice and democratic processes.

There is one narrow way out. Under Art. 6(3), an Annex III system is not high-risk if it only does a narrow procedural or preparatory task posing no significant risk. A system that profiles people is always high-risk. More on the high-risk AI system page.

General-purpose AI (GPAI) models follow Chapter V (Arts. 51 to 56). Every GPAI provider must keep technical documentation, inform downstream providers, adopt a copyright policy and publish a training-content summary (Art. 53). Models with systemic risk, presumed above 10²⁵ FLOPs of training compute, add evaluations, adversarial testing, incident reporting and cybersecurity (Art. 55). See general-purpose AI model.

When does the EU AI Act apply?

The Act applies in stages. The 2026 Digital Omnibus moved the high-risk dates but left the early milestones alone. The Commission's AI Act Service Desk timeline shows the amended dates.

DateWhat applies
1 Aug 2024Entry into force
2 Feb 2025Prohibited practices (Art. 5) and AI literacy (Art. 4)
2 Aug 2025GPAI model obligations, governance bodies and penalties
27 Jul 2026The Digital Omnibus, Regulation (EU) 2026/1744, enters into force
2 Aug 2026Most remaining rules, including Art. 50 transparency, AI Office enforcement powers and Commission fines for GPAI providers
2 Dec 2026Two new Omnibus prohibitions; Art. 50(2) marking deadline for generative systems on the market before 2 Aug 2026
2 Aug 2027GPAI models placed on the market before 2 Aug 2025 must comply; national AI regulatory sandboxes operational
2 Dec 2027Annex III high-risk obligations (originally 2 Aug 2026)
2 Aug 2028Annex I high-risk obligations (originally 2 Aug 2027)
2 Aug 2030Legacy high-risk systems used by public authorities must comply

High-risk systems already on the market before their application date are caught only if significantly changed afterward. The exception is systems used by public authorities, which must comply by 2 Aug 2030. Our AI Act clock lesson drills these dates.

What are the main obligations?

Obligations depend on your role and the system's tier.

Providers of high-risk AI

  • Meet the seven requirements in Arts. 9 to 15. They cover risk management, data governance, technical documentation, logging, instructions for use and human oversight. The seventh is accuracy, robustness and cybersecurity.
  • Run a quality management system (Art. 17).
  • Complete a conformity assessment (Art. 43), sign an EU declaration of conformity (Art. 47) and affix the CE marking (Art. 48).
  • Register Annex III systems in the EU database before launch (Art. 49).
  • Monitor the system after launch (Art. 72) and report serious incidents (Art. 73). The deadline is 15 days after awareness, or 10 days if a person dies. It is 2 days for a widespread infringement or serious critical-infrastructure disruption.

Deployers of high-risk AI

  • Use the system according to the provider's instructions (Art. 26).
  • Assign human oversight to trained people with the authority to intervene.
  • Check that input data under their control is relevant and sufficiently representative.
  • Keep automatically generated logs for at least six months.
  • Inform workers before workplace use, and tell people when a high-risk system helps make decisions about them.
  • Complete a fundamental rights impact assessment before first use if they are a public body or a private entity providing public services (Art. 27). The duty also covers credit scoring and life or health insurance pricing. A FRIA can now cross-reference a DPIA; see FRIA vs DPIA.

Importers and distributors

Importers (Art. 23) and distributors (Art. 24) verify that a high-risk system carries the CE marking, declaration of conformity and instructions. They must not supply a system they have reason to believe does not conform.

Everyone

AI literacy under Art. 4 applies to providers and deployers of all AI systems. Since the Omnibus, they must take measures to support their staff's AI literacy, rather than guarantee a set level.

What are the penalties?

Fines under Art. 99 scale with the rule broken.

BreachMaximum fine
Prohibited practices (Art. 5)€35 million or 7% of worldwide annual turnover
Most other obligations, including operator duties and Art. 50 transparency€15 million or 3%
Incorrect, incomplete or misleading information to authorities or notified bodies€7.5 million or 1%
GPAI model providers (Art. 101, imposed by the Commission)€15 million or 3%

For most companies, the cap is whichever amount is higher. For SMEs, including start-ups, it is whichever is lower (Art. 99(6)). The Omnibus added Art. 99(6a), which extends the lower-of rule to small mid-cap enterprises (SMCs) for the €15 million and €7.5 million tiers only.

Example: a company with €2 billion in turnover that uses a prohibited practice faces up to €140 million. That is 7% of turnover, which beats €35 million.

Who enforces the EU AI Act?

Enforcement runs on two levels: national authorities for most AI systems and the Commission for GPAI models.

  • National market surveillance authorities police AI systems on their markets. Each Member State must designate at least one, plus a notifying authority that oversees notified bodies (Art. 70).
  • The AI Office, part of the European Commission, supervises GPAI models. Since the Omnibus, amended Art. 75 also makes it exclusively competent for AI systems built on a provider's own GPAI model, with some exclusions. The same applies to AI in very large online platforms and search engines.
  • The European AI Board, made up of Member State representatives, advises and coordinates. It does not fine anyone.
  • The European Data Protection Supervisor acts as the market surveillance authority for EU institutions.

Anyone can complain to a market surveillance authority (Art. 85). People affected by significant decisions based on Annex III high-risk AI have a right to an explanation (Art. 86).

What changed with the 2026 Digital Omnibus?

The Digital Omnibus on AI is Regulation (EU) 2026/1744. The Commission proposed it on 19 November 2025. It was signed on 8 July 2026, published on 24 July 2026 and entered into force on 27 July 2026.

What changed:

  • Fixed high-risk dates. Annex III moved to 2 Dec 2027 and Annex I to 2 Aug 2028. The proposal had tied them to standards being ready.
  • Two new prohibitions from 2 Dec 2026. One covers AI that generates non-consensual intimate or sexual images, video or audio of an identifiable person. The other covers AI that generates child sexual abuse material.
  • Marking grace period. Generative systems on the market before 2 Aug 2026 have until 2 Dec 2026 for Art. 50(2) marking (new Art. 111(4)).
  • AI literacy and bias data. Softer Art. 4 wording, and a new Art. 4a legal basis to process special-category data for bias detection.
  • Small mid-caps. SME simplifications and the lower-of fine rule extended to SMCs for the two lower tiers.
  • FRIA and DPIA. A FRIA may cross-reference a DPIA (Art. 27(4)), and the AI Office will provide a questionnaire template.

What did not change: the original prohibitions, GPAI obligations, penalty tiers, the Art. 50 date and the Art. 73 incident deadlines.

How does the AIGP exam test the EU AI Act?

The exam leans on classification, roles, dates and fines.

  • Classify by use. If a question describes the technology but not the purpose, pick the answer that asks what the system is for.
  • Watch the role flip. Rebranding, substantially modifying or repurposing a system into high-risk makes you the provider.
  • Mind the date version. BoK v2.1 was approved in September 2025, before the Omnibus. Check whether a question asks about the law as adopted or as amended.
  • Don't swap fine tiers. Remember 35/7, 15/3 and 7.5/1. The GDPR's €20 million or 4% is a separate regime.
  • FRIA is a deployer duty. Conformity assessment, CE marking and registration are provider duties.

Our AI Act in one-liners lesson maps each key article to a single sentence.

Change log

  • 7 Nov 2026: Page published.

Pages in this guide

Frequently asked questions

When does the EU AI Act apply to high-risk AI?

After the 2026 Digital Omnibus, duties for Annex III high-risk systems (such as hiring, credit scoring and education) apply from 2 December 2027. Duties for Annex I systems, meaning AI in regulated products like medical devices or machinery, apply from 2 August 2028. The original dates were 2 August 2026 and 2 August 2027. Systems already on the market are caught only if significantly changed, except those used by public authorities, which must comply by 2 August 2030.

Does the EU AI Act apply to US companies?

Yes, if they place AI systems or GPAI models on the EU market or their AI's output is used in the EU (Art. 2). A US provider of a high-risk system sold in the EU must meet the provider duties and appoint an EU authorized representative. Purely domestic US use, with no EU market or EU output, falls outside its scope.

What are the fines under the EU AI Act?

Prohibited practices: up to €35 million or 7% of worldwide annual turnover. Most other obligations, including GPAI providers: €15 million or 3%. Misleading information to authorities: €7.5 million or 1%. Large companies face the higher figure. SMEs and start-ups face the lower one. Since the 2026 Omnibus, small mid-caps also get the lower figure for the two lower tiers.

Did the Digital Omnibus delay the EU AI Act?

Only in part. Regulation (EU) 2026/1744 deferred the high-risk duties to 2 December 2027 (Annex III) and 2 August 2028 (Annex I). It did not delay the prohibitions, GPAI obligations, penalties or Art. 50 transparency, which still applied from 2 August 2026. It also added two new prohibitions that apply from 2 December 2026.

Is a general-purpose AI model high-risk under the EU AI Act?

Not by itself. GPAI models follow their own rules in Chapter V, with extra duties for models with systemic risk. A system built on a GPAI model is classified by its use, though. A chatbot used to screen job applicants is an Annex III high-risk system. Whoever puts it into service for that purpose carries the high-risk duties.

Sources

  1. EUR-Lex: Regulation (EU) 2024/1689 (Artificial Intelligence Act)
  2. EUR-Lex: Regulation (EU) 2026/1744 (Digital Omnibus on AI)
  3. European Commission AI Act Service Desk: implementation timeline
  4. European Commission: The European AI Office
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