The output of the applicability test should be a record that another reviewer can repeat. It should include the product facts, classification answer, source citation, owner, role decision, risk route, excluded-facts analysis, and the evidence used to support each conclusion.
For high-risk systems, the record should point to the downstream compliance artifacts: technical documentation, risk management, data governance, logging, instructions for use, human oversight, accuracy, robustness, cybersecurity, conformity assessment, registration, post-market monitoring, incident reporting, and deployer monitoring where relevant. For GPAI models, preserve model documentation, downstream provider information, representative mandate where required, and systemic-risk material where applicable.
What is the first question in an EU AI Act applicability test?
Ask what object is being classified: an AI system, a GPAI model, traditional rules-based software, or a manual activity. The AI system definition turns on machine-based inference of outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.
Can a system be in an Annex III area but still be treated as not high-risk?
Yes, Article 6(3) allows a provider to classify certain Annex III systems as not high-risk where the system does not pose a significant risk of harm and meets the listed conditions, such as a narrow procedural task or preparatory task. The provider should document the assessment and register the system as required.
What evidence should teams keep for the EU AI Act applicability test?
Keep the system or model description, intended purpose, EU scope facts, exclusion analysis, operator-role map, prohibited and high-risk screens, transparency and GPAI checks, source URLs, approvals, attached product evidence, and reassessment triggers.