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Record STMT-W4949DCSoft law

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

Guidelines International lawEuropean Uniondraft

These draft European Commission guidelines support providers, deployers, and market surveillance authorities in assessing whether an AI system should be classified as high-risk under the EU AI Act. The document interprets key classification concepts and provides practical examples of AI systems that should or should not be classified as high-risk under both product safety legislation and Annex III use cases. It aims to facilitate the uniform application and effective enforcement of Article 6 of the AI Act.

Summary and content fields are drawn from the document text and are pending editorial review.

Who issued it

European CommissionGovernment (executive)
Lead issuer
Legal forceSoft law
Under whose authorityInternational law
Judged fromfull text

Who it governs

AI developers and providersRegulatorsCompaniesAI deployers and users

AI providers, deployers, and market surveillance authorities should read this to understand how to correctly classify high-risk AI systems under the EU AI Act.

Sectors
Cross-sector

What the document contains

What's covered

The document covers the interpretation of high-risk AI classification concepts under Article 6 of the EU AI Act, detailing scenarios involving products governed by EU harmonization legislation and specific use cases across various domains.

What's missing

The text does not provide final adopted rules, as it is a draft open for stakeholder feedback, nor does it contain comprehensive technical standards for every specific industry.

Key takeaways
  • The guidelines assist in assessing whether an AI system qualifies as high-risk under Article 6 of the EU AI Act.
  • The text provides practical examples of AI systems that should or should not be classified as high-risk.
  • High-risk classification applies to safety components of products covered by EU harmonization legislation requiring third-party conformity assessment, or specific use cases listed in Annex III.
  • The practical examples provided are non-exhaustive and subject to updates over time.
Outline
· Section I: General principles
· Section III: AI systems as safety components of products under Annex I
· Section IV: AI systems falling into use cases under Annex III
Issued19 May 2026
Length422 words
FormatNot recorded
Scoperegional

How it scores

Pending review

Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.

Accountability

0/5

Clear responsibility for AI outcomes

screening score · 2026-10-23

Fairness

0/5

Non-discrimination and equitable treatment

screening score · 2026-10-23

Human Dignity

0/5

Respect for the inherent worth of persons

screening score · 2026-10-23

Human Oversight

0/5

Humans remain in control of consequential decisions

screening score · 2026-10-23

Privacy

0/5

Protection of personal data and private life

screening score · 2026-10-23

Transparency

1/5

Openness about how AI systems work and are used

The Guidelines set out the Commission’s interpretation of certain concepts that are relevant for classification purposes

Paragraph 1

screening score · 2026-10-23

Enforcement

1/5

Consequences and compliance mechanisms with real force

facilitating the uniform application and effective enforcement of Article 6 AI Act

Paragraph 1

screening score · 2026-10-23

Impact Assessment

1/5

Required assessment of an AI system's risks/impacts before or during use

assessing whether an AI system should be classified as high-risk

Paragraph 1

screening score · 2026-10-23

Topics

artificial_intelligence high_risk_ai compliance eu_ai_act market_surveillance