The Malta Digital Innovation Authority (MDIA) is hosting an informative session titled “AI in MedTech: Preparing for the EU AI Act” on July 17, 2026. This hybrid event aims to equip stakeholders, including medical device manufacturers and healthcare innovators, with insights into the implications of the EU AI Act for AI-powered medical devices and digital health solutions.
The session is particularly timely as AI's integration into medical technology is becoming essential for diagnostics and patient care. Attendees will learn how the AI Act interacts with existing regulations like the MDR and IVDR, and understand the classification of AI systems as high-risk. The event will also address how organizations can incorporate AI compliance into their existing frameworks rather than creating new systems from scratch, alongside updates on the Digital Omnibus on AI.
Experts from various sectors, including Dr. Dylan Attard and representatives from regulatory bodies, will participate in a panel discussion to provide practical insights into the evolving regulatory landscape. This is crucial as the AI Act is being phased in, with significant deadlines approaching, including new transparency obligations in August 2026 and the regulation of high-risk AI systems by 2028.
As the event approaches, the MDIA encourages early registration for in-person attendance due to limited spots. Furthermore, the MDIA has established an AI Service Desk for ongoing support regarding the EU AI Act. This event not only serves as a primer for compliance but also sets the stage for continued discussions at the upcoming MedTech World Europe 2026 in Malta, where industry leaders will explore the future of AI in healthcare.