Experts Call for Streamlined EU AI Framework and Increased AI Literacy in Healthcare
During the RAPS AI in Regulatory Conference in Barcelona, experts advocated for a more streamlined regulatory framework for AI in European healthcare products and urged regulatory professionals to enhance their AI literacy. Leander Vranken, manager for AI and digital health at MedTech Europe, stressed the need for immediate implementation of a workable AI regulatory framework, highlighting concerns about AI products navigating parallel regulatory frameworks like the AI Act, Medical Device Regulation (MDR), and In Vitro Diagnostics Regulation (IVDR. This duplication leads to increased administrative burdens and costs. Sebastian Fischer, regulatory strategy principal at TÜV SÜD, argued that the AI Act was designed for integration, citing Article 43 which combines MDR and AI Act requirements. However, Erik Vollebregt, an attorney at Axon Lawyers, expressed less confidence in seamless integration, pointing to unresolved issues. Experts also cautioned against overreliance on AI, emphasizing critical thinking an...