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The Malta Digital Innovation Authority (MDIA) is hosting a hybrid information session, “AI in MedTech: Preparing for the EU AI Act,” on Friday, 17th July 2026, from 14:00 to 17:00, at DiHubMT in Birkirkara, with a live stream available for those joining online. The session is built for stakeholders including medical device manufacturers, healthcare innovators, and compliance professionals who want a clearer picture of how the EU AI Act will actually affect AI-powered medical devices, in-vitro diagnostics, and digital health solutions, through expert talks and a panel discussion with voices from across the sector.
AI is no longer a side feature in MedTech; it’s becoming core to how devices work, how diagnoses are supported, and how care is delivered. That shift means the EU AI Act isn’t a distant regulatory concern anymore; it’s something manufacturers and providers need to plan for today. The session will help attendees make sense of how the AI Act interacts with the MDR and IVDR, when an AI system used in a medical context counts as high-risk, and what that means in practice for manufacturers, providers, deployers, and other operators along the chain. There will also be a look at how AI obligations can be built into existing compliance processes instead of creating a separate system from scratch, plus an update on the Digital Omnibus on AI and the simplification measures and revised timelines it could bring.
The panel discussion brings together experts from across the MedTech and regulatory world, including Dr. Dylan Attard, CEO and Co-founder of MedTech World, and expert speakers from the MDIA, the Malta Medicines Authority, and the Office of the Information and Data Protection Commissioner, who will share grounded, practical perspectives on where the regulatory landscape is heading and what it means for businesses on the ground.
The AI Act is in force, yet doesn’t switch on all at once; it’s being phased in over several years, and a few key dates are worth having on your radar. It came into force back on 1st August 2024, and rules on prohibited AI systems and AI literacy started applying on 2nd February 2025. Since 2nd August 2025, requirements around notified bodies, general-purpose AI models, governance, confidentiality, and penalties have been in effect. The next major milestone lands on 2nd August 2026, when further rules including the transparency obligations under Article 50 kick in, so AI-generated patient results, for instance, will need to be clearly flagged as AI-generated. Further down the line, high-risk AI systems under Annex III come into scope on 2nd December 2027, covering things like AI used to prioritise patients or referrals in public healthcare, and high-risk AI embedded in regulated products under Annex I, such as certain types of diagnostic imaging or lab testing software, will be regulated from 2nd August 2028. Worth noting: this timeline reflects the latest changes proposed under the Digital Omnibus on AI and is still subject to final approval. With the Article 50 deadline arriving just weeks after this event, the timing couldn’t be more relevant.
The session takes place on Friday, 17th July 2026, from 14:00 to 17:00, at DiHubMT, MDIA, Level 1, Twenty20 Business Centre, Triq L-Intornjatur, Zone 3, Central Business District, Birkirkara, CBD 3050, and will also be streamed online for anyone joining remotely. In-person places are limited, so those planning to attend on-site are encouraged to register early. To confirm attendance, fill in the online registration form by Wednesday, 15 July 2026, close of business. Any questions can be sent to the MDIA at [email protected].
Beyond the event, the MDIA has set up a dedicated AI Service Desk for anyone with questions about the EU AI Act, reachable at [email protected]. More detail on AI system risk classification, Malta’s competent authority structure, and available compliance tools is available on the MDIA website.
As the regulatory landscape for AI in healthcare continues to evolve, staying informed is only the first step. The conversation will continue at MedTech World Europe 2026, taking place in Malta from 11 to 13 November, where global leaders across medtech, digital health, investment, and regulation will come together to discuss the latest developments shaping the industry. For organisations preparing for the next phase of AI-enabled healthcare, it offers an opportunity to continue learning, exchange practical insights, and connect with the people driving innovation across Europe. Book your spot now.
