EU publishes regulation governing use of AI in medical devices and IVDs
In this article:
- Purpose: Promote the uptake of “human-centric and trustworthy” AI for medical devices, in vitro diagnostic devices (IVDs), and other products.
- Scope: Establishes a legal framework with harmonized rules for placing AI products on the market.
- Significance: Recognized as the world’s first comprehensive AI law by the European Parliament.
- Publication Date: Published in the Official Journal on 12 July.
- Effective Date: The Act goes into effect on 2 August.
- High-Risk Device Requirements: Requirements for high-risk devices will go into effect on 2 August 2026.
- Legislative History: Text unchanged from the AI Act adopted by the European Parliament on 13 March.
