Compliance

Instructions for Use

Mandatory documentation that providers must supply with high-risk AI systems to enable compliant deployment and use.

Definition

Instructions for Use is mandatory documentation that providers of high-risk AI systems must supply to enable deployers to use the system in compliance with the AI Act. Required content is specified in Article 13.

Required Content (Article 13):

  • Identity and Contact: Provider name and contact details
  • System Characteristics:
    • Intended purpose
    • Level of accuracy, robustness, and cybersecurity
    • Any known limitations
    • Specifications for input data
  • Changes: Any changes to the system through its lifecycle
  • Human Oversight: Human oversight measures and technical means to facilitate interpretation of outputs
  • Computing Resources: Expected lifetime, maintenance and care measures
  • Logging: Description of logging capabilities

Purpose:

  • Enable deployers to fulfill their own obligations
  • Ensure proper human oversight
  • Facilitate correct interpretation of AI outputs
  • Support risk management by deployers
  • Enable informed decision-making by users

Format Requirements:

  • Must be clear, understandable, and appropriate to the target users
  • Must be in an official language of the Member State where the system is placed on the market
  • Should be kept up to date throughout the system's lifecycle

Deployer Reliance: Deployers are entitled to rely on instructions for use to fulfill their compliance obligations, provided they follow them correctly.

Sources

  • EU AI Act Article 13
  • EU AI Act Annex IV