The EU AI Act creates a tiered risk-based regime. The middle and most-regulated tier is "high-risk." Article 6 defines two routes into high-risk: (1) AI systems that are safety components of products covered by EU sectoral law listed in Annex I (e.g. medical devices, machinery, toys, vehicles), or (2) AI systems used in the eight areas listed in Annex III.
What are the eight Annex III areas?
Biometrics; critical infrastructure (water, gas, electricity, traffic); education and vocational training (admission, evaluation, monitoring); employment and worker management (recruitment, performance evaluation, task allocation); access to essential private services and essential public services (creditworthiness, public-benefit eligibility, emergency triage, life and health insurance); law enforcement (risk assessments, polygraph-like tools, evidence reliability); migration, asylum, and border control; administration of justice and democratic processes.
What does Article 6(3) "filter" do?
Article 6(3) added a filter: an AI system in an Annex III area is NOT high-risk if it does not pose a significant risk of harm to the health, safety, or fundamental rights of natural persons. Four conditions can lift it out of high-risk: (a) narrow procedural task, (b) improvement of human-completed activity, (c) detection of decision-making patterns or deviations, or (d) preparatory task to a relevant assessment. Profiling of natural persons always stays in high-risk.
What are the obligations for providers of high-risk systems?
A risk management system across the lifecycle (Article 9), data and data governance for training, validation, and testing (Article 10), technical documentation per Annex IV (Article 11), record-keeping/automatic logging (Article 12), transparency and instructions for use (Article 13), human oversight by design (Article 14), accuracy/robustness/cybersecurity (Article 15), a quality management system (Article 17), conformity assessment and CE-marking (Articles 43–49), registration in the EU database (Article 49), and post-market monitoring (Article 72).
What about deployers?
Deployers of high-risk AI systems have lighter but real obligations under Article 26: use the system per the provider’s instructions, ensure relevant input data is appropriate for the intended purpose, monitor operation and report incidents, retain logs, and — for certain Annex III systems used by public authorities or large private deployers — conduct a Fundamental Rights Impact Assessment (FRIA) under Article 27.
When do high-risk obligations apply?
Regulation (EU) 2026/1744 (the Digital Omnibus on AI, in force since 27 July 2026) deferred the high-risk rules: stand-alone Annex III systems must comply from 2 December 2027, and AI that is a safety component of Annex I products (medical devices, machinery, etc.) from 2 August 2028. Under Article 111(2), high-risk systems already on the market before the rules apply only need to comply if they undergo significant changes in design, except systems intended for use by public authorities, which have until 2 August 2030. The Article 50 transparency duties are separate and apply from 2 August 2026.