EU AI Act and MDR: Impacts and future challenges to address

As AI-driven medical technologies are taking root in the healthcare landscape, regulatory frameworks evolve to keep pace. The EU AI Act and MDR introduced new requirements that will shape how AI-powered medical devices are developed, tested, and brought to market. This session will examine the impacts of these new implementations, as well as those we can foresee. How do regulatory bodies and medical devices manufacturers and suppliers face these significant challenges? How are they navigating compliance? How can different stakeholders participate in shaping discussions with regulatory bodies?