Draft Guidelines for Classification of High-Risk AI Systems under the AI Act

On May 19, 2026, the European Commission published draft guidelines clarifying the classification of high-risk artificial intelligence (AI) systems under the AI Act. These guidelines are intended to assist providers, deployers, and other relevant stakeholders in determining whether an AI system falls within the high-risk category. The guidelines offer practical examples and clarifications on relevant provisions of the AI Act, supporting compliance and enforcement.

A targeted public consultation is open until June 23, 2026, inviting feedback on the clarity and usefulness of the guidelines. Only responses submitted via the official online questionnaire will be considered for the final version. The guidelines are accessible in a user-friendly format on the AI Act Single Information Platform, allowing stakeholders to browse relevant areas and use cases.

The AI Act identifies two main types of high-risk AI systems: those embedded in products regulated under Union harmonised product safety legislation, and those that can significantly affect health, safety, or fundamental rights in specific use cases. The guidelines aim to clarify these classifications and provide practical support for compliance.

Rules for certain high-risk AI systems, including those used in biometrics, critical infrastructure, education, employment, migration, asylum, and border control, will apply from December 2, 2027. For AI systems integrated into products such as robotics and industrial machinery, the rules will apply from August 2, 2028. The guidelines are not legally binding but reflect the Commission's interpretation and will guide enforcement.

This measure is assessed as Medium Impact. The guidelines are currently in draft form and open for public consultation, meaning they are not yet final or legally binding. However, they are expected to significantly influence the classification and compliance obligations for high-risk AI systems across multiple sectors once adopted.

Key reasons for Medium Impact:

• The guidelines clarify classification criteria for high-risk AI systems under the AI Act.
• They provide practical examples for stakeholders, supporting compliance and enforcement.
• The consultation process allows for stakeholder input, which may lead to important changes in the final version.
• The guidelines will affect providers, deployers, and users of AI systems in areas such as biometrics, critical infrastructure, education, employment, migration, and robotics.

Who is affected?

• AI providers and developers
• Organizations deploying AI systems
• Public authorities
• Researchers and civil society organizations
• Supervisory bodies

Conclusion:

While the guidelines are not yet mandatory, their adoption will have a substantial impact on compliance and operational practices for high-risk AI systems in the EU. Stakeholders should monitor developments and prepare for potential changes in classification and obligations.