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Regulation (EU) 2024/1689, as amended by Regulation (EU) 2026/1744
01What it is
The AI Act regulates artificial intelligence by risk. It prohibits specified practices, imposes substantial obligations on high-risk systems, applies transparency duties to some others, and regulates general-purpose AI models in their own right. What falls outside those categories escapes the high-risk requirements, not the Regulation: the AI literacy duty in Article 4 binds every provider and deployer, whatever the tier.
Everything therefore turns on classification — which systems fall inside, and in which role. Get that wrong and every downstream obligation is wrong with it.
02Who it applies to
The operators listed in Article 2: providers, deployers, importers and distributors of AI systems placed on the market or put into service in the EU, providers of general-purpose AI models, authorised representatives of providers established outside the Union, and product manufacturers placing a system on the market together with their product under their own name or trademark.
The role is not fixed. A deployer that fine-tunes a model, puts its own name on a system, or substantially modifies it can become a provider — with the obligations that follow. Most organisations occupy more than one role across their estate.
03Core obligations
04Timeline
05Where it meets the other regimes
The deferral that was widely misread
Regulation (EU) 2026/1744, the Digital Omnibus on AI, entered into force on 27 July 2026 and deferred the high-risk obligations in Sections 1, 2 and 3 of Chapter III, excluding Article 6(5). Section 4, on notifying authorities and notified bodies, has applied since 2 August 2025. It did not defer the Regulation, which has been generally applicable since 2 August 2026 under the second paragraph of Article 113. It did not defer Article 4 on AI literacy, which has applied since February 2025 — although it did rewrite it, replacing the duty to ensure a sufficient level of AI literacy with a duty to take measures supporting it. Articles 51 to 55 on general-purpose AI were left in place. Organisations that read 'deferral' and stopped work are wrong about which parts were deferred.
The two new prohibitions are conditional, and the conditions do the work
Article 5(1a) splits the test. Placing on the market or putting into service is prohibited only where that generation or manipulation is the intended purpose of the system, or where the system's design, training, architecture, capabilities or user-facing functionalities make it a reasonably foreseeable and reproducible outcome without significant technical modification, and the system lacks reasonable and adequate safeguards to prevent and correct that misuse. Use is prohibited only where the deployer uses the system for that purpose. Article 5(1b) excludes manipulation that neither increases the exposure of any depicted intimate parts nor alters the nature of any depicted sexually explicit activities.
For a general-purpose system, the question is therefore not whether the output is possible but whether the safeguards hold — which is an evidential question, assessed against reasonably foreseeable misuse, and one that has to be answered before 2 December 2026.
AI Act ↔ GDPR
Where the system processes personal data, both apply, and they ask different questions. The AI Act asks about classification, documentation and oversight. The GDPR asks about lawful basis for training data, transparency to the people affected, and Article 22 on automated decisions. Each requires its own assessment on its own terms.
AI Act ↔ NIS2 and DORA
Where the AI system sits in critical infrastructure, NIS2 governs the security of the environment around it. Where the deployer is a financial entity, DORA governs the ICT risk, including where the model is supplied by a third party.
06What we are instructed on
AI Act classification and role determination, governance frameworks, procurement and contracting, impact assessments, and readiness reviews.
Digital regulation applies to systems, not to documents. We work where law, technology and governance actually meet — which is where the obligations bite.