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EU AI Act - Technical Documentation Requirements for High-Risk AI Systems (Article 11 and Annex IV)

EU AI Act (Regulation 2024/1689) Article 11 requires providers of high-risk AI systems to draw up technical documentation before the system is placed on…

What EU AI Act - Technical Documentation Requirements for High-Risk AI Systems (Article 11 and Annex IV) requires

EU AI Act (Regulation 2024/1689) Article 11 requires providers of high-risk AI systems to draw up technical documentation before the system is placed on the market or put into service and to keep it up-to-date throughout the AI system's lifecycle; Annex IV specifies the mandatory minimum content of the technical documentation; the technical documentation serves two functions: (1) enabling market surveillance authorities and notified bodies to assess whether the AI system complies with EU AI Act requirements; (2) providing a comprehensive record of the AI system's development, capabilities, limitations, and risk management measures; Annex IV technical documentation minimum content includes: a general description of the AI system including: intended purpose; the persons or groups it is intended to be used by; the contexts of intended use; the known or foreseeable circumstances where the system may be improperly used; the information sheet for the system including a summary for users; a detailed description of the system elements and its development process covering: design specifications; training methodologies; design choices and assumptions; design limitations; training data sources and characteristics; training data labelling and annotation procedures; data pre-processing operations; dataset validation; a description of monitoring, functioning, and control including: the measures for human oversight; the system's capabilities, limitations, and accuracy levels; a description of the risk management measures; a description of the changes made after the conformity assessment for systems that undergo a substantial modification; technical documentation must be retained for 10 years from the date of placing on the market or putting into service under Article 18 or for the period the system remains in service where longer; technical documentation must be provided to national competent authorities and notified bodies upon request.

Pillar: AI Governance & Law · Authority: European Parliament and Council of the EU · Version: 1.0.0 · Last updated:

Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689

SHA-256 integrity: dbb31ba934fff56462a6d1bd3e96bc3f1be50c784a76c0c7c255a97bdbe61018

Primary Citations — 5 traced to source

  • {"title":"Regulation (EU) 2024/1689 - EU AI Act: Article 11 - Technical Documentation","url":"https://eur-lex.europa.eu","relevance":"Primary EU AI Act provision establishing the technical documentation obligation for high-risk AI system providers - Article 11 requires documentation before market placement, mandates updates throughout the lifecycle, and references Annex IV as the minimum content specification"}
  • {"title":"Regulation (EU) 2024/1689 - EU AI Act: Annex IV - Technical Documentation as Referred to in Article 11(1)","url":"https://eur-lex.europa.eu","relevance":"EU AI Act Annex IV specifying the mandatory minimum content of technical documentation - Annex IV is the definitive technical documentation template specifying required elements covering system description, development process, training data, performance metrics, accuracy levels, human oversight design, and risk management measures"}

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