EU AI Act

DEFINITION

The EU AI Act is the European Union's regulatory regime for artificial intelligence. Provisional political agreement was reached December 2023, formal adoption proceeded through 2024, and staged enforcement began August 2025. The Act operationalises ISO/IEC 42001's management-system posture for high-risk AI use cases, imposing conformity assessment, post-market monitoring, and incident reporting obligations comparable in posture to medical device regulation. Article 26 places the burden of demonstrating compliance on the deployer of the AI system, not the provider — a structural cornerstone of the Defensibility framework.