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European Union · Guidance

European Union — Conformity Assessment Guidelines for High-Risk AI Systems

In force1 August 2026

Issued by European AI Office and National Notified Bodies.

Summary

The European Union’s 2026 conformity assessment guidance marked the operational phase of the AI Act’s high-risk system requirements. From August 2026, AI systems used in areas such as hiring, medical devices, critical infrastructure, credit scoring, and law enforcement must meet strict obligations before deployment. Requirements include high-quality training data, cybersecurity controls, continuous technical logging, documentation, and meaningful human oversight. Organisations must work with independent notified bodies to secure certification, placing AI compliance closer to established audit regimes used in medical devices and aviation.

Why it matters

High-risk AI conformity assessments; certification through notified bodies; high-quality training data; robust cybersecurity; continuous technical logs; documentation; meaningful human oversight; applies to hiring, medical devices, critical infrastructure, credit scoring, and law enforcement.

Topics

Record metadata

Country
European Union
Region
Europe
Organisation
European AI Office and National Notified Bodies
Document type
Guidance
Status
In force
Publication date
1 August 2026
Last updated
27 June 2026
Language
English
Original source
View original source

Citation export

Plain citation

European AI Office and National Notified Bodies, Conformity Assessment Guidelines for High-Risk AI Systems, 2026.

BibTeX

@misc{eu_conformity_assessment_guidelines_high_risk_ai_systems_2026,
  title        = {European Union — Conformity Assessment Guidelines for High-Risk AI Systems},
  author       = {European AI Office and National Notified Bodies},
  year         = {2026},
  howpublished = {Global AI Governance Archive},
  url          = {https://digital-strategy.ec.europa.eu/en/policies/european-ai-office}
}

See the citation guide for style-specific examples.

Recorded cross-references

  • European Union — Regulation (EU) 2024/1689 Artificial Intelligence Act
  • European Union — AI Act 2025 Ban Phase-In and GPAI Guidelines
  • Council of Europe Framework Convention on AI

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