Industrial Engineer-Medical Device engineering, quality & regulatory expert-Founder KEYMED Devices-Professor Biomechanics,ITBA
EU publishes regulation governing use of AI in medical devices and IVDs Regulatory News | 15 July 2024 | Joanne S. Eglovitch The European Commission has published the finalized text of the Artificial Intelligence Act (AIA) which establishes a legal framework to promote the uptake of “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices (IVDs) and other products. The Act also sets harmonized rules for placing products on the market, and is the world’s first comprehensive AI law, according to the European Parliament.