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Annex III: high-risk AI

Classification route for standalone high-risk AI systems under Article 6(2) and Annex III.

The official source remains authoritative. This general interpretation is not legal advice.

Status
Upcoming
Application date
2 December 2027
Version
1.0.0
Last reviewed
8 August 2026

Who this is relevant to

When this applies

  • Deployer

    An organisation using an AI system under its authority, excluding personal non-professional use.

  • Provider of an AI system

    A party that develops or has an AI system developed and places it on the market under its own name.

  1. 1The intended purpose falls within a use case listed in Annex III.
  2. 2Classification follows Article 6(2).

What the official source establishes

The core rules in Chapter III, Sections 1 to 3, for systems under Article 6(2) and Annex III become applicable on 2 December 2027.

Our interpretation

The later application date does not remove the classification question. An early classification record avoids design and procurement decisions without evidence.

What you can do now

Document now the intended purpose, Annex III point, Article 6(3) assessment, profiling and selected registration path.

  1. 01

    Classify the use case and document the outcome

    Assess Article 5, Article 6 and Annex III in that order and document purpose, context and any Article 6(3) exception.

What to retain

Article 6 and Annex III classification record

Traceable rationale covering intended purpose, Annex III category, Article 6(3) assessment and registration decision.

Control and reassessment

  • Reclassification on purpose or context change

    Reopen classification when intended purpose, use context or system functionality changes materially.

Public tools

Conditions and exceptions

  • A listed Annex III system may fall outside high-risk under the strict conditions in Article 6(3), except where it profiles. The assessment and registration must be documented.

Official sources and locators

  • Digital Omnibus on AI 2026/1744

    European Parliament and Council | official-journal-2026-07-24

    Source locator: Amended Article 113, Article 6(2) and Annex III application date

  • EU Artificial Intelligence Act 2024/1689

    European Parliament and Council | original-oj-2024-07-12

    Source locator: Article 6 and Annex III

  • EU Artificial Intelligence Act 2024/1689

    European Parliament and Council | original-oj-2024-07-12

    Source locator: Article 6(2)-(4), Article 49 and Annex III

Version history

  1. v1.0.0

    27 July 2026

    Annex III: high-risk AI

    Classification route for standalone high-risk AI systems under Article 6(2) and Annex III.

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