European Commission Launches Stakeholder Consultation on the EU AI Act's Rules for High-Risk AI Systems

On June 6, 2025, the European Commission launched a public consultation to gather input on the implementation of the EU Artificial Intelligence (AI) Act provisions and obligations related to high-risk AI systems. This public consultation aims to inform the upcoming guidelines that the European Commission is drafting. More specifically, the European Commission seeks to collect input from stakeholders on practical examples of AI systems and issues to be clarified in these guidelines regarding the classification of high-risk AI systems, the related requirements and obligations, as well as responsibilities along the AI value chain.

All interested stakeholders have until July 18, 2025 to share their input by responding to the questionnaire available here.

The questionnaire for the consultation is divided into five sections:

• Sections 1 and 2 focus on the classification rules for high-risk AI systems. The European Commission is particularly seeking input on how the notion of "safety component" should be interpreted, examples of AI systems that can be considered themselves as products covered by EU laws listed under Annex I, and the exemptions to the classification of high-risk AI systems under Annex III.
• Section 3 covers the notion of the "intended purpose" of an AI system and how this notion should be clarified.
• Section 4 focuses on the obligations applicable to Providers and Deployers of high-risk AI systems, as well as the concept of "substantial modification" and the subsequent risk of requalification as Provider of high-risk AI systems for other actors in the AI value chain.
• Section 5 seeks input on potential updates to the lists of high-risk use cases set out in Annex III of the EU AI Act and prohibited AI practices.

Participation in this public consultation is a unique opportunity to shape the EU AI regulatory framework. Businesses are therefore highly encouraged to take part, particularly those active in the Life Sciences, Financial Services, Transportation, Critical Infrastructure, and Technology sectors. Steptoe is well-prepared to assist in crafting an effective response.

For a refresher on the notion of "High-risk AI systems" and the related obligations applicable to the different actors across the AI value chain, please consult our EU AI Act Decoded series.

For more information, please contact Anne-Gabrielle Haie.