Annex III Classification Changes and Updates

Legal Framework

Article 106 of the AI Act is the central provision governing changes to Annex III, the list of high-risk AI systems. This article empowers the European Commission to adopt delegated acts to update the Annex in order to account for technological developments, new scientific evidence, and changes in the use or functionality of AI systems. The process is a distinct regulatory mechanism, separate from the general review of the AI Act itself. When exercising this power concerning AI systems that are safety components under the Machinery Regulation (EU) 2024/1689, the Commission must take into account the specific conformity assessment requirements set out in that Regulation.

Practical Application

The delegated act procedure under Article 106 provides the primary pathway for the list of high-risk systems to evolve. This means the classification of an AI system can change from non-high-risk to high-risk, or vice versa, without amending the core AI Act text. In practice, the Commission will initiate this process based on monitoring and evidence collection, likely following recommendations from the AI Office and the Board. Organizations must monitor for the publication of draft and final delegated acts in the Official Journal, as these will have direct legal effect. A system moved into Annex III becomes subject to all Chapter III high-risk obligations, including conformity assessment, while a system removed is relieved of those burdens.

Key Considerations

• Proactive Monitoring: Companies must establish a regulatory monitoring process specifically for Commission delegated acts amending Annex III, as these changes can immediately alter the compliance status of deployed or planned AI systems.
• Impact Assessment for New Entries: If an AI system type is newly listed in Annex III, providers must conduct a gap analysis against all high-risk requirements (quality management, technical documentation, conformity assessment, etc.) and initiate the necessary compliance processes.
• Coordination with Machinery Rules: For providers of AI systems that are safety components of machinery, any classification update must be analyzed in parallel with the specific conformity assessment procedures mandated by the Machinery Regulation.