{"id":33018,"date":"2024-08-29T09:30:54","date_gmt":"2024-08-29T07:30:54","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/08\/29\/ue-in-gazzetta-ufficiale-lartificial-intelligence-act-aia\/"},"modified":"2024-08-29T11:44:05","modified_gmt":"2024-08-29T09:44:05","slug":"ue-in-gazzetta-ufficiale-lartificial-intelligence-act-aia","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/08\/29\/ue-in-gazzetta-ufficiale-lartificial-intelligence-act-aia\/","title":{"rendered":"EU: The Artificial Intelligence Act (AIA) included in the EU Official Journal"},"content":{"rendered":"

The European Commission has made available the final text of the Artificial<\/strong> Intelligence Act (AIA)<\/strong>, the world’s first comprehensive regulatory framework dedicated to artificial intelligence. This regulation defines a harmonised set of rules to promote ‘reliable, human-centred’ artificial intelligence,<\/strong> applicable to medical devices, in vitro diagnostic devices (IVD) and other products.<\/strong> The AIA aims to ensure the safe placing of these products on the market, as also recognised by the European Parliament<\/h2>\n

Published in the Official Journal on<\/strong> July<\/strong> 12<\/strong>, the Regulation came into force on August<\/strong> 2, 2024, <\/strong>with the requirements for high-risk devices<\/strong> becoming mandatory on<\/strong> August 2, 2026.<\/strong><\/p>\n

The AIA aims to improve market functioning by prohibiting specific AI practices and introducing additional obligations for high-risk AI systems. In addition, the regulation requires AI system providers and operators to ensure that their personnel have an appropriate level of expertise.<\/p>\n

Obligations for High-Risk AI Devices <\/strong><\/h2>\n

The AI Act includes several provisions relevant to medical devices that integrate or rely on artificial intelligence.<\/strong> However, the legislation does not treat all applications in the same way. By adopting a risk-based approach, a large part of the new compliance, reporting and liability obligations will be mainly borne by ‘suppliers’ (Art. 3(3), AI Act) of AI components or solutions considered ‘high risk’<\/strong>, Class IIa or higher<\/strong>.<\/p>\n

The regulation specifies that manufacturers of high-risk medical devices must implement a risk management system for the entire product life cycle<\/strong>, ensure governance to certify that the data are error-free, and produce technical documentation to prove compliance with the regulation.<\/p>\n

Among his many obligations, the manufacturer must:<\/p>\n