EU AI Act and its 1 linked instrument

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EU AI ActHMA-EMA AI workplan
AuthorityEuropean UnionEMA
Legal weightLaw & regulationGuidance & Q&A
StatusEffective · phasedFinal
Last verifiedNot yetNot yet
Summary

Horizontal EU law on AI systems, applying in phases. AI literacy duties already apply; transparency duties (Art. 50) apply from 2 August 2026. The 2026 digital omnibus moved high-risk obligations to December 2027 (Annex III) and August 2028 (Annex I, e.g. devices).

Joint HMA and EMA workplan for artificial intelligence in medicines regulation, 2023 to 2028. It is a plan, not a requirement.

Lifecycle
  • 1 Aug 2024 Entered into force (obligations phased)
  • 27 Jul 2026 Digital Omnibus on AI, Regulation (EU) 2026/1744, in force (published in the Official Journal 24 Jul 2026); defers high-risk obligations
  • 2 Aug 2026 Article 50 transparency duties apply (Art. 50(2) marking for systems already on the market: 2 Dec 2026, per the Omnibus)
  • Target 2 Dec 2027 Annex III high-risk obligations apply
  • Target 2 Aug 2028 Annex I (product-embedded, e.g. devices) high-risk obligations apply
  • 18 Dec 2023 Published
SourceOfficial text
Source: European Union. Licensed under CC BY 4.0.
Official text
Source: EMA.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.