Summary AI Regulation for AI-enabled medical devices is entering a period of significant change. While the European Commission has proposed
Summary The European Commission’s proposed Digital Omnibus package could significantly reshape how the GDPR applies to medical device manufacturers, particularly
Summary Artificial intelligence is rapidly becoming part of the quality and regulatory landscape. From drafting procedures and technical documentation to
Summary Update, October 2026: Since this article was written, the draft has been published as EN 18286:2026, and the Commission
Summary Cybersecurity has become a central topic across the European digital regulatory landscape. While medical device manufacturers have already been
Summary The European Parliament’s proposal to move product-regulated AI systems from Section A to Section B of the AI Act
Summary When the MDR and IVDR entered into force, Article 5(5) created a specific framework for medical devices developed and
Summary By the time teams reach the submission phase, the assumption is often that the hardest decisions are behind them.
Summary In Part II of this series, Leon shifts the focus from initial regulatory positioning to one of the most
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