EU AI Act: what changed

1. 27 July 2026

   Digital Omnibus in force: Article 4 AI literacy rewritten

   What changed

   Before, providers and deployers had to ensure, to their best extent, a sufficient level of AI literacy of their staff. Now they must take measures to support the development of AI literacy, taking into account knowledge, experience, education, training and the context of use. The new text states that no specific level of AI literacy of any individual has to be guaranteed. The Commission and the member states support providers and deployers, in particular SMEs.

   What it means for life sciences

   The obligation stays, its standard changes: measures instead of a guaranteed level. The text does not explicitly require documentation. Being able to show which measures you took, such as training, guidelines and clear responsibilities, is still the practical proof when a customer, an auditor or an authority asks.

   Source

   Regulation (EU) 2026/1744 of 8 July 2026, Official Journal L of 24 July 2026, in force on the third day after publication.

2. 27 July 2026

   High-risk obligations postponed

   What changed

   The rules for high-risk AI systems (Chapter III, Sections 1 to 3) were due to apply from 2 August 2026, and from 2 August 2027 for products under Annex I. The Digital Omnibus moves them to 2 December 2027 for high-risk systems under Article 6(2) and Annex III, and to 2 August 2028 for those under Article 6(1) and Annex I.

   What it means for life sciences

   AI in medical devices and in vitro diagnostics that need a notified body falls under Annex I and gains one year, until 2 August 2028. AI in areas listed in Annex III, for example recruiting and HR, follows from 2 December 2027. The extra time is preparation time for technical documentation and quality management, not a pause.

   Source

   Regulation (EU) 2026/1744, recitals on the date of application of Chapter III.

3. 2 August 2026

   Most of the AI Act applies

   What changed

   This is the general date of application of the AI Act. From this date most of its provisions apply, except the high-risk obligations that the Digital Omnibus moved.

   What it means for life sciences

   Every AI system in use now needs a clear answer to one question: is your company the provider or the deployer? The obligations follow from that role.

   Source

   Regulation (EU) 2024/1689, Article 113.

4. 2 August 2025

   Rules for general-purpose AI models and governance apply

   What changed

   Chapter V on general-purpose AI models applies, together with Chapter VII on governance, Chapter XII on penalties, Chapter III Section 4 on notifying authorities and notified bodies, and Article 78.

   What it means for life sciences

   For most life sciences companies this matters indirectly: the providers of the large language models your teams use now carry obligations of their own. For medical devices, the setup of notified bodies under the AI Act began.

   Source

   Regulation (EU) 2024/1689, Article 113(b).

5. 2 February 2025

   Prohibited practices and AI literacy apply

   What changed

   Chapters I and II apply: the general provisions, including the AI literacy duty in Article 4, and the prohibited AI practices in Article 5.

   What it means for life sciences

   Article 4 has applied to every company that uses AI since this date. Its wording was changed in July 2026, see the first entry.

   Source

   Regulation (EU) 2024/1689, Article 113(a).

6. 1 August 2024

   The AI Act enters into force

   What changed

   Regulation (EU) 2024/1689 of 13 June 2024 enters into force on the twentieth day after its publication. Its rules apply in stages.

   What it means for life sciences

   The clock starts. The staged dates above all count from this regulation.

   Source

   Regulation (EU) 2024/1689, Article 113.

Not legal advice. This log summarises the official texts and adds my assessment for life sciences. For your own product, your regulatory affairs team or a lawyer decides. How my free checks apply these rules is explained on the methodology page.