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Draft Commission guidelines on the classification of high-risk AI systems

The European Commission released draft guidelines to help AI providers, deployers, and market surveillance authorities classify high-risk AI systems under Article 6 of the AI Act. The guidelines interpret key classification concepts and provide practical examples of systems that should or should not be considered high-risk, covering two scenarios: systems used as safety components of regulated products and systems falling under use cases listed in Annex III. The Commission is seeking targeted stakeholder feedback on the draft, which is divided into separate sections for easier access and review.

read2 min publishedMay 19, 2026

These Guidelines aim to support providers and deployers of AI systems, as well as competent market surveillance authorities, in assessing whether an AI system should be classified as high-risk, thereby facilitating the uniform application and effective enforcement of Article 6 AI Act.

The Guidelines set out the Commission’s interpretation of certain concepts that are relevant for classification purposes and, in accordance with Article 6(5) AI Act, contain practical examples of AI systems that should or should not be classified as high-risk. The examples listed in these Guidelines strive to cover all areas and use cases, but they are not to be considered as exhaustive and may be updated over time.

The guidelines are divided into sections, following the structure of Article 6 of I Act, which states that an AI system shall be considered high-risk in 2 scenarios:

  • If the system is intended to be used as a safety component of a product, or the AI system itself is a product, covered by the EU harmonisation legislation listed in Annex I, and the product whose safety component is the AI system or the AI system itself is required to undergo a third-party conformity assessment, the system will be classified as high-risk pursuant to Article 6(1) AI Act.
  • If the system falls into one of the use cases listed under the areas in Annex III AI Act, it will be classified as high-risk pursuant to Article 6(2) AI Act.

Section III of the guidelines addresses the first category of high-risk AI systems, while section IV addresses the second category. Below, you can download each section separately, so you do not need to consult the full document if they are only interested in a specific area or use case. This is intended to make the draft guidelines easier to access, share and use for feedback.

Find more information about the targeted stakeholder consultation on these guidelines.

Downloads #

1- Draft Guidelines on the classification on high-risk AI: General principles

Download 2 - Draft Guidelines on the classification of high risk AI systems: Annex I of AI Act

Download 3 - Draft Guidelines on the classification of high risk AI systems: Annex III of AI Act

Download

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