New EU Artificial Intelligence Regulation Enters into Force

The Artificial Intelligence Regulation (AI Act) was published in the Official Journal of the EU in July 2024. Certain provisions banning unacceptable-risk AI systems have applied since 2 February 2025, while the main application date is set for 2 August 2026.
The AI Act establishes harmonised rules for all AI systems placed on the market or used in the EU, regardless of whether they are already regulated under other sector-specific laws. Medical devices and IVDs incorporating AI are considered high-risk, and from 2 August 2027 will require conformity assessment, CE marking, and a Declaration of Conformity.
The regulation applies to providers, deployers, importers, distributors, and authorised representatives of AI systems. It also establishes a European AI Office and a European AI Board to oversee implementation and ensure coordination across the EU.