🟡 ⚖️ Regulation Published: · 2 min read ·

EU AI Office: Public Consultation on High-Risk AI System Classification — Deadline June 23, 2026

Editorial illustration: European Commission opens public consultation on draft guidelines defining when an AI system falls under the high-risk category

The European Commission has opened a public consultation on draft guidelines defining when an AI system falls under the "high-risk" category of the AI Act. Stakeholders — from developers to civil society — can submit feedback until June 23, 2026 at 10 PM CET.

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This article was generated using artificial intelligence from primary sources.

The EU AI Office, the European Commission’s regulatory body responsible for implementing the AI Act, has launched a targeted public consultation on draft guidelines that clarify when an AI system falls into the high-risk category — the critical legal threshold that determines the scope of obligations for AI technology providers and users.

What Does the EU AI Office Want to Define With These Guidelines?

The AI Act (EU Regulation 2024/1689) — the regulatory framework the European Union adopted in 2024 to manage the risks of artificial intelligence — classifies AI systems into four levels: prohibited, high, limited and minimal risk. High-risk AI systems are subject to the strictest requirements: mandatory documentation, testing, transparency and registration in the EU database.

The draft guidelines published by the EU AI Office for consultation provide practical clarifications and sector-by-sector examples to help providers and user organizations assess their system’s status themselves. There are two main high-risk categories: AI embedded in products subject to EU safety legislation (medical devices, machinery, vehicles) and AI systems that may significantly affect the health, safety or fundamental rights of individuals — for example in education, employment, credit scoring, biometric identification or critical infrastructure management.

Why Is High-Risk Classification a Contested Question?

The boundary between a “high-risk” and a “limited risk” AI system is not always clear from the regulation text. Providers who incorrectly assess their system’s status face legal uncertainty, while overly strict classification criteria could slow innovation. The goal of the EU AI Office guidelines is to reduce this interpretive uncertainty through concrete examples by application category, harmonize enforcement across member states, and reduce compliance costs for development teams and organizations using AI.

Who Can Participate and By When?

The consultation is open to all interested parties — AI system developers and providers, user organizations, public bodies, researchers, civil society organizations and citizens. Responses are submitted via an online questionnaire on the ec.europa.eu/eusurvey platform. The deadline for submitting responses is June 23, 2026 at 10 PM CET. Questions should be sent to [email protected].

Frequently Asked Questions

What is the AI Act and why are guidelines needed?
The AI Act (EU Regulation 2024/1689) is the first comprehensive regulatory framework for artificial intelligence at the European Union level, adopted in 2024. It introduces four risk levels — prohibited, high, limited and minimal risk. The EU AI Office guidelines elaborate the criteria that help AI system providers and users assess whether their system falls into the high-risk category.
Which AI systems may be classified as high-risk?
The AI Act defines two main groups. The first covers AI embedded in products subject to existing EU safety legislation (e.g. medical devices, machinery). The second group includes AI systems that may significantly affect the health, safety or fundamental rights of individuals — for example in education, employment, credit scoring, biometric identification and critical infrastructure.
Who can participate in the consultation and how?
The consultation is open to all interested parties — AI system providers and developers, organizations that use AI, public bodies, researchers, civil society organizations and citizens. Responses are submitted via an online questionnaire at ec.europa.eu/eusurvey, with a deadline of June 23, 2026 at 10 PM CET.