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European Commission launches a public consultation on the implementation of the rules applicable to high-risk AI systems

On June 6, 2025, the European Commission launched a public consultation to gather feedback from stakeholders (e.g. providers and deployers of high-risk AI systems, industry organisations, independent experts, public authorities) on the implementation of the provisions applicable to high-risk AI systems (“Consultation”), as set out in Regulation (EU) 2024/1689 of 13 June 2024 on artificial intelligence [1] ("RIA").

The AI Act follows a risk-based approach, classifying AI systems into four categories, including high-risk AI systems, which are subject to a set of obligations that will apply to some of them as of August 2, 2026.

Under Article 6 of the AI Act, high-risk AI systems fall into two categories :

  • AI systems intended to be used as a safety component of a product covered by a Union harmonisation legislation listed in Annex I to the AI Act, or AI systems that themselves constitute such a product (Art. 6(1) AI Act) ;
  • AI systems listed in Annex III to the AI Act which, by virtue of their intended purpose, present a significant risk to health, safety or fundamental rights (Art. 6(2) AI Act).

Pursuant to Article 6(5) AI Act, the European Commission must, by February 2, 2026, issue guidelines setting out the practical implementation of Article 6. These guidelines must be accompanied by a list of practical examples of AI use cases that are considered high-risk and those that are not. In addition, Article 96(1)(a) AI Act requires the Commission to provide guidelines on the practical implementation of the requirements for high-risk AI systems and the obligations of operators, as well as on liability throughout the AI value chain as provided for in Article 25 AI Act.

The Consultation, therefore, seeks stakeholder contributions to prepare these guidelines and invites them to comment, in particular, on the following topics :

  • the classification rules for high-risk AI systems under Article 6(1) and Annex I of the AI Act ;
  • the classification rules for high-risk AI systems under Article 6(2) and Annex III of the AI Act, including the Article 6(3) mechanism that allows certain AI systems not to be considered high-risk subject to specific conditions ;
  • high-risk classification and, in particular, possible overlaps between the classification regimes under Annexes I and III of the AI Act ;
  • the requirements and obligations applicable to high-risk AI systems and the requirements relating to the value chain ;
  • the need to amend the list of high-risk use cases in Annex III and the prohibited AI practices set out in Article 5 of the AI Act.

The Consultation, available here, is open until 18 July 2025.