High-risk AI system (EU AI Act)

Under the EU AI Act, an AI system that is either a safety component of a product covered by the EU product laws listed in Annex I, or is used in one of the areas listed in Annex III: biometrics, critical infrastructure, education, employment, access to essential services, law enforcement, migration, and the administration of justice. Providers must run a risk management system, data governance, documentation, logging, human oversight and a conformity assessment before placing it on the EU market; Indian companies that sell such systems into the EU are caught. After the Digital Omnibus on AI (Regulation (EU) 2026/1744, adopted 8 Jul 2026), the Annex III obligations apply from 2 Dec 2027 and the Annex I obligations from 2 Aug 2028.