EU AI Act Annex III - High-Risk AI Systems List

[in effect]

European Union · standard · standard

Jurisdiction

European Union

Classification

standard

Status

in effect

Effective Date

Aug 2, 2026

Primary Sources

1 audited

Statutory Scope & Summary

Annex III of the EU AI Act lists high-risk AI systems including safety components of vehicles, medical devices, and critical infrastructure. Providers must implement risk management, data governance, transparency, human oversight, and conformity assessment before market placement.

Covered Sectors & Application Domains

Regulatory Analysis & Inquiries

6 entries
What does EU AI Act Annex III - High-Risk AI Systems List cover?

Annex III of the EU AI Act lists high-risk AI systems including safety components of vehicles, medical devices, and critical infrastructure. Providers must implement risk management, data governance, transparency, human oversight, and conformity assessment before market placement.

Where does EU AI Act Annex III - High-Risk AI Systems List apply?

EU AI Act Annex III - High-Risk AI Systems List is recorded as a standard applying in European Union on the DEPLOY registry.

When did EU AI Act Annex III - High-Risk AI Systems List take effect?

EU AI Act Annex III - High-Risk AI Systems List is recorded as effective August 2, 2026 on the DEPLOY registry.

Is EU AI Act Annex III - High-Risk AI Systems List still in effect?

EU AI Act Annex III - High-Risk AI Systems List is currently in effect and applies to covered operators in the named jurisdiction.

What types of robots does EU AI Act Annex III - High-Risk AI Systems List apply to?

EU AI Act Annex III - High-Risk AI Systems List is recorded as applying to autonomous vehicles, surgical, robots on the DEPLOY registry.

Which robot models on the DEPLOY registry fall under EU AI Act Annex III - High-Risk AI Systems List?

8 robot models on the DEPLOY registry match the form-factor scope of EU AI Act Annex III - High-Risk AI Systems List: 10Beauty Manicure System, 1Rollo, 3D Tissue Braiding Platform, 7 Series DPO Oscilloscope and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.

Primary Sources & Legal Instruments

1 document
  • https://artificialintelligenceact.eu/annex-3/

    https://artificialintelligenceact.eu/annex-3/

    Official Source