TR-004HighProviderPreventive
Known Limitations Notice in IFU
Providers must include in the instructions for use any known or foreseeable circumstances in which the AI system may fail to perform as intended, conditions of use that may lead to risks, and the populations or contexts for which the system was not designed.
Articles:Article 13(3)(b)(iii)Article 13(3)(b)(v)
Evidence Examples
- Limitations section in IFU
- Contraindication list
- Out-of-scope use warnings
Standards
ISO 42001:2023 §8.3
Related controls
- 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…
- TR-002Intended Purpose DisclosureProviders must clearly communicate the intended purpose of the AI system, the specific context and use cases for which it was designed, and the categories…
- TR-003Performance Metrics Disclosure to DeployersThe instructions for use must include the performance metrics for which the system has been designed and the level of accuracy that the provider committed…
- TR-005Human Oversight Guidance for DeployersInstructions for use must provide deployers with information about human oversight measures required, including the competencies needed to interpret…
- TR-006Input Data SpecificationsThe instructions for use must describe the form and type of data required as inputs to the AI system, the formats expected, and any constraints on input…
- TR-007AI System Identification at DeploymentProviders must ensure AI systems intended to interact directly with natural persons are designed and developed so those persons are informed that they are…
Related EU AI Act terms
- Instructions for UseInformation 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.
- Transparency RequirementsObligations under Article 13 requiring that high-risk AI systems are designed to ensure that their operation is sufficiently transparent to enable deployers to interpret the system's output and use it appropriately, and under Article 50 for specific systems (chatbots, synthetic content) to notify persons they are interacting with AI.
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