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AI Act: scope and obligations

Regulation: EU 2024/1689 Applicability: Generally from 2 August 2026, with earlier and later dates. Chapter III, Sections 1–3, except Article 6(5), applies from 2 December 2027 for Annex III and 2 August 2028 for Annex I under Article 113. Article 111 governs transitional rules for existing systems and models. Scope: Artificial Intelligence


What is the AI Act?

The AI Act sets rules for AI systems and models. Obligations depend on the organisation’s role, the system’s purpose and risks, and the date when the relevant provision applies.

How to determine the requirements for a system

What to checkBasis for the decision
Prohibited useThe precise conditions and exceptions in Article 5. A feature name is insufficient; purpose, use and impact matter.
High-risk statusThe product route in Article 6(1) / Annex I or a specified use in Article 6(2) / Annex III, including paragraph 3.
TransparencyArticle 50 distinguishes AI interaction, synthetic content, deepfakes and other specified cases. Duties depend on role and exceptions and can overlap high-risk status.
Other usesThis does not automatically mean “no obligations”. Assess AI literacy, GDPR, contracts and other applicable requirements separately.

The conclusion concerns a particular system and purpose, not a product name or industry. The classification guide provides further questions.

Key Obligations

For HIGH-RISK AI Systems

Articles 9–15 primarily set requirements for providers of high-risk systems. Deployers have the different duties in Article 26; they do not automatically take over the provider’s full technical documentation. Annex I products also require the applicable sectoral conformity route.

ObligationDescriptionDeadline
Risk managementEstablished, documented and maintained risk management system across the lifecycle (Art. 9)Ongoing; testing at the latest before placing on the market or putting into service
Data GovernanceTraining data quality, bias testingOngoing
Technical documentationDocumentation under Article 11 and Annex IV; a model card alone is insufficientBefore placing on the market or putting into service, then keep updated
Record KeepingAutomatically generated logs under the actor’s control: appropriate period, at least 6 months unless other applicable law provides otherwise (Arts. 19, 26(6))Ongoing
Transparency to deployersSufficient interpretability and instructions for use under Article 13Before placing on the market or putting into service
Human oversightMeasures proportionate to the risks, autonomy and context under Article 14System design and use
Accuracy & RobustnessTesting, monitoring, drift detectionOngoing

Using systems based on GPAI models

The Chapter V duties concern providers of GPAI models, not every customer using a model API. First identify whether you use an existing AI system, develop and supply your own system, or provide a GPAI model.

  • Review the intended purpose, instructions, limitations and supplier terms.
  • Support AI literacy for staff and others operating AI on your behalf, appropriate to their roles (Art. 4); a particular course or certificate is not mandated.
  • Agree a GDPR Article 28 processing contract where the supplier processes personal data on your behalf. A DPA is not required merely because non-personal company data is involved.
  • Decide what evidence and logs are necessary for your use case; do not retain every prompt by default.
  • Before entering personal or confidential data, establish a lawful purpose, access rules, a suitable contract, transfer safeguards and proportionate security. Encryption alone does not make processing lawful.

Your Role

RoleDefinitionExample
ProviderDevelops or has a system/model developed and places it on the market or puts the system into service under its name or trademarkAn integrator supplying its own AI application may be a provider without training the underlying model
DeployerUses an AI system under its authority in a professional contextA company using an existing assistant; its own supplied application must be assessed separately
ImporterA person located or established in the EU placing on the market a system bearing the name or trademark of a person established outside the EUAssess the actual market role; using a foreign API alone is insufficient
DistributorA supply-chain actor other than the provider or importer making a system available on the EU marketReselling a system under Article 3’s conditions

Timeline

Penalties

ViolationPenaltyLegal basis
Prohibited practices (Art. 5)up to €35M or 7% of total worldwide annual turnover — whichever is higherArt. 99(3)
Other obligations — including high-risk duties (Art. 16, 22-24, 26) and transparency (Art. 50)up to €15M or 3% — whichever is higherArt. 99(4)
Incorrect, incomplete or misleading information supplied in response to a request from notified bodies or national competent authoritiesup to €7.5M or 1% — whichever is higherArt. 99(5)

Mind the direction of the comparison: for undertakings the higher of the two values applies, not the lower. SMEs including start-ups are the exception — for them the lower value applies (Art. 99(6)). Regulation (EU) 2026/1744 added the same rule for small mid-cap enterprises, but only for paragraphs 4 and 5 — not for prohibited practices (new Art. 99(6a)).

Example (not an SME or small mid-cap enterprise): A company with €100M annual turnover breaches high-risk obligations. 3% of turnover = €3M, the fixed cap is €15M — the maximum fine is the higher value, i.e. €15M; the actual amount is set under Art. 99(7). For prohibited practices it would be 7% = €7M against a €35M cap, i.e. €35M.


Next Steps

  1. Conduct AI inventory
  2. Classify risks
  3. Review checklist

Resources



Primary sources: AI Act — informative consolidated version 27 July 2026; Regulation (EU) 2026/1744 — published 24 July 2026; GDPR — published version 4 May 2016.