Wednesday, September 30, 2026

10:15 - 11:00

AUDITORIUM MARGARITA SALAS

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Overview

Sponsor: Asphalion

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Artificial intelligence is transforming medical devices, particularly software-based technologies for early disease detection and personalised healthcare. However, in 2026 AI-powered medical devices in Europe will operate under a dual regulatory framework shaped by Regulation (EU) 2017/745 (MDR) and the Artificial Intelligence Act, creating one of the most complex compliance environments globally. This session will bring together a Notified Body representative, a startup with an AI-based speech analysis platform for early detection of dementia, Parkinson’s disease and cardiovascular conditions, and regulatory strategy experts. The panel will provide a multidisciplinary and practice-oriented discussion on how innovative AI solutions can successfully reach the European market. Key discussion points include: Qualification and classification of AI-based software as medical devices Clinical evidence expectations for machine learning systems Lifecycle management of adaptive algorithms Interaction between MDR and the AI Act requirements Data governance and high-risk AI systems Regulatory pitfalls and common deficiencies identified by Notified Bodies Strategic considerations for startups scaling internationally The discussion will address whether Europe can maintain global competitiveness in digital health while ensuring patient safety and regulatory robustness. By combining regulatory authority perspective, industry experience and strategic advisory insight, this session offers a practical roadmap for innovators navigating AI medical device development in Europe.

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