EU publishes final text of Artificial Intelligence Act

The European Commission has published the final text of the Artificial Intelligence Act (AIA) which establishes a legal framework for “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices (IVDs) and other products. The Act also sets harmonized rules for placing such products on the Community market.

The AIA was published in the Official Journal on 12 July 2024 and will go into effect on 2 August 2025, while the requirements for high-risk devices will go into effect one year later, on 2 August 2026. The text is unchanged from the AI Act adopted by the European Parliament on 13 March. “High risk” covers devices in Class IIa and above under the Medical Device Regulation (MDR, 2017/745).

The Act aims to improve the functioning of the internal market, prohibits certain AI practices and adds specific requirements for high-risk AI systems. It does not apply to research or testing activities prior to placing products on the market.