AI Risk Assessment (AIRA) — EU AI Act Methodology
How to conduct an AI Risk Assessment (AIRA) for EU AI Act compliance. 5-step methodology, who needs it, and how Scanara automates the process.
An AI Risk Assessment (AIRA) is the structured process required under EU AI Act Article 9 for every high-risk AI system. It identifies foreseeable risks, evaluates their likelihood and severity, and documents mitigation measures before deployment. All providers of Annex III high-risk AI systems must complete an AIRA before placing the system on the EU market — with enforcement from August 2, 2026. Non-compliance carries fines of up to €15 million or 3% of global turnover.
Who Must Conduct an AIRA?
Article 9 applies to providers of high-risk AI systems listed in Annex III of Regulation (EU) 2024/1689. The 8 high-risk categories cover biometrics, critical infrastructure, education, employment, essential services, law enforcement, migration, and justice. If your AI system falls into any of these categories, an AIRA is mandatory.
Biometric identification systems
Critical infrastructure management
Education & vocational training AI
Employment & HR decision AI
Essential public/private services AI
Law enforcement AI systems
Migration & border control AI
Administration of justice AI
The 5-Step AIRA Methodology
The methodology below aligns Article 9 obligations with ISO/IEC 23894:2023 (AI risk management guidance) and the EU AI Act's iterative lifecycle requirement.
Identify Risks
Enumerate all known and reasonably foreseeable risks across the AI system lifecycle — training data, model outputs, deployment context, and third-party integrations. Document the intended use and foreseeable misuse scenarios per Annex IV §1.
Classify Risk Severity
Rate each identified risk by likelihood and impact severity. Apply the Annex III classification to confirm the system is high-risk. Reference Article 9(2)(a) for the evaluation criteria: harm to health, safety, or fundamental rights.
Evaluate Mitigation Options
For each material risk, identify technical and procedural mitigation measures. Consider inherent safeguards, training data quality controls (Art 10), human oversight mechanisms (Art 14), and accuracy/robustness requirements (Art 15).
Implement Mitigations
Apply the selected measures in your codebase and processes. Document implementation evidence — logging configurations, override mechanisms, monitoring alerts — to form part of the Annex IV technical documentation.
Monitor & Update Continuously
Article 9(3) requires the AIRA to be updated throughout the system lifecycle. Establish periodic review triggers (model updates, new deployment contexts, incident reports) and maintain an audit trail of all revisions.
ISO/IEC 23894 and the EU AI Act
ISO/IEC 23894:2023 provides the internationally recognised framework for AI risk management, complementing Article 9. While compliance with the standard is not mandatory under the Act, using it as a methodology foundation creates an auditable, standards-aligned AIRA that satisfies national market surveillance authorities. Key alignment points: the standard's iterative risk treatment cycle maps directly to Article 9(2), and its documentation requirements align with Annex IV technical file obligations.
How Scanara Automates AIRA
Code-level risk detection
Scanara scans your repository with compliance rules mapped to every Article 9 obligation — flagging missing risk identification, evaluation, and mitigation implementations.
Annex IV documentation generation
Scan results feed directly into auto-generated Annex IV technical documentation in PDF, DOCX, HTML, or Markdown format, ready for regulatory submission.
Continuous monitoring
GitHub merge gates prevent non-compliant code from shipping. Each commit is scanned against the full AIRA rule set, maintaining your Article 9(3) lifecycle obligation.
Frequently Asked Questions
How Scanara Helps
Scanara automates EU AI Act compliance from code to dossier. Connect your GitHub repos and get compliance reports in minutes.