High risk compliance is a lifecycle system with evidence at every stage.
This checklist covers both the core requirements and the surrounding provider and deployer duties that make them real.
Structured answer sets in this page tree.
Cited legal and guidance references.
High risk systems require more than principles. They require structured controls, technical and organizational evidence, and release discipline that remains valid after deployment. This page maps the key requirements to the outputs teams should be able to show.
Article 9 requires a continuous and iterative risk management system. It should cover known and reasonably foreseeable risks across the lifecycle, not only risks at initial design. Article 10 requires data governance and data quality measures appropriate to the system and its intended purpose.
This is where many high risk programs rise or fall. If the training, validation, and testing record is thin, later claims about performance and oversight will also be weak.
Article 11 requires technical documentation with the Annex IV content needed to demonstrate compliance. Article 12 requires automatic logging capabilities. Article 13 requires instructions for use that let deployers understand capabilities, limitations, expected performance, and required oversight.
This is not paperwork for paperwork sake. These materials allow deployers, notified bodies, and authorities to understand how the system should be used and where the limits are.
Article 14 requires human oversight measures that fit the system and its context. The assigned natural persons need competence, training, authority, and practical means to intervene. Article 15 requires an appropriate level of accuracy, robustness, and cybersecurity in light of intended purpose and state of the art.
Oversight and performance should be designed together. A strong oversight model fails if operators cannot understand outputs or if the system degrades without usable monitoring.
Core requirements only work if the surrounding duties are also in place. Providers need quality management, conformity assessment, retention, registration, and post market monitoring. Deployers need to use the system according to instructions, assign oversight, keep logs under their control, inform affected persons in relevant cases, and perform FRIA where Article 27 requires it.
This is why high risk readiness is always broader than Articles 9 to 15 alone.
A high risk system is not done at first release. Post market monitoring, serious incident handling, corrective action, and change review all need named owners and templates. Learning systems and major updates also need careful review to determine whether the change was already assessed or becomes substantial.
Your release checklist should therefore be paired with a steady state monitoring checklist.
Assessment Autopilot can take EU AI Act (Regulation (EU) 2024/1689) High risk checklist from turning this checklist into an operational workflow to a reusable workflow inside Sorena. Teams working on EU AI Act (Regulation (EU) 2024/1689) can keep owners, evidence, and next steps aligned without copying this guide into separate documents.
Start from EU AI Act (Regulation (EU) 2024/1689) High risk checklist and turn the guidance into owned tasks, evidence requests, and review checkpoints.
Review your current process, evidence gaps, and next steps for EU AI Act (Regulation (EU) 2024/1689) High risk checklist.