DocumentationArticle 3(19)Article 13
Instructions for Use
Information provided by the provider of a high-risk AI system to inform deployers about the system's intended purpose, performance characteristics, limitations, maintenance requirements, human oversight mechanisms, and the technical measures needed to ensure the system can be effectively overseen by natural persons.
Related terms
- Technical DocumentationThe documentation that providers of high-risk AI systems must draw up before placing the system on the market, containing all necessary information to…
- Logging CapabilitiesThe automatic recording of events by a high-risk AI system during its operation — required under Article 12 to enable monitoring of its operation,…
- EU Database for High-Risk AI SystemsA publicly accessible EU-wide database established and maintained by the European Commission, in which providers of high-risk AI systems listed in Annex…
- AI SystemA machine-based system designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or…
- Risk-Based ApproachThe overarching regulatory framework of the EU AI Act that categorises AI systems by the level of risk they pose — prohibited, high-risk, limited-risk,…
- Placing on MarketThe first making available of an AI system or a general-purpose AI model on the Union market, in the course of a commercial activity, whether for payment…
Related compliance controls
- RM-007Residual Risk Documentation and DisclosureProviders must document residual risks that users need to be informed of and include relevant information in the system instructions for use, enabling deployers to manage remaining risks appropriately.
- RM-010Risk Communication to StakeholdersProviders must communicate relevant risk information to deployers, affected persons, and competent authorities as required, including risk summaries in the instructions for use and technical documentation.
- TD-007Known Limitations DocumentationArticle 11 and Annex IV require explicit documentation of known or foreseeable limitations of the AI system, including performance degradation conditions, out-of-distribution failure modes, and contexts where the system should not be used.
- TR-001User Instructions for UseArticle 13(1) requires providers to supply high-risk AI systems with instructions for use containing the information necessary for deployers to understand the system's capabilities, limitations, and conditions for safe and effective deployment.
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