The AI Act is the EU’s horizontal law on artificial intelligence. It regulates AI systems according to the risk their use poses to health, safety and fundamental rights. A small number of practices are prohibited. AI systems used in defined high-risk areas, or as safety components of regulated products, must meet requirements before they are placed on the market and while in use. Some systems carry transparency duties, and general-purpose AI models have their own set of obligations.
What an organisation must do depends on its role. Providers, who develop an AI system or have it developed and place it on the market under their own name, carry most of the obligations for high-risk systems: risk management, data governance, technical documentation, logging, human oversight, accuracy and robustness, a quality management system and conformity assessment. Deployers, who use a system under their own authority, must use it according to its instructions, assign human oversight, monitor it and keep logs. Importers and distributors have checking duties.
The Act applies in phases. Prohibitions and AI literacy have applied since 2 February 2025, and the obligations for general-purpose AI models, governance and penalties since 2 August 2025. Most remaining provisions, including the transparency obligations in Article 50, have applied since 2 August 2026. Regulation (EU) 2026/1744, the Digital Omnibus on AI, deferred the high-risk obligations: they now apply from 2 December 2027 for the stand-alone areas in Annex III and from 2 August 2028 for AI in products covered by Annex I legislation.
The same amending regulation added two prohibited practices, applying from 2 December 2026, reframed the AI literacy duty in Article 4, extended some simplifications to small mid-cap enterprises and strengthened the AI Office’s enforcement powers. Organisations often use a management system standard such as ISO 42001:2023 or the NIST AI RMF 1.0 to run AI governance, but neither replaces the legal assessment of obligations under the Act.