July 8, 2026
2026 Starts with a High-Level of Legal Uncertainty for AI/Ml-Enabled Medical Devices
Summary AI Regulation for AI-enabled medical devices is entering a period of significant change. While the European Commission has proposed
Read more
July 1, 2026
GDPR’s New Direction: What MedTech Needs to Know
Summary The European Commission’s proposed Digital Omnibus package could significantly reshape how the GDPR applies to medical device manufacturers, particularly
Read more
June 22, 2026
Automating Regulatory Compliance: The Future of Quality and Regulatory?
Summary Artificial intelligence is rapidly becoming part of the quality and regulatory landscape. From drafting procedures and technical documentation to
Read more
June 10, 2026
prEN 18286, future of the EU’s AI management system standard
Summary The regulatory landscape for AI-enabled medical devices continues to evolve, and one of the latest developments attracting attention is
Read more
June 2, 2026
Cybersecurity Resilience Act (CRA, 2024/2847) and Health Software
Summary Cybersecurity has become a central topic across the European digital regulatory landscape. While medical device manufacturers have already been
Read more
May 28, 2026
AI Act Section A to B: Minimal change or far-reaching consequences?
Summary The European Parliament’s proposal to move product-regulated AI systems from Section A to Section B of the AI Act
Read more
May 19, 2026
Article 5(5) Redesigned: Sharing In-House Medical Software Across Hospitals
Summary When the MDR and IVDR entered into force, Article 5(5) created a specific framework for medical devices developed and
Read more
May 18, 2026
AI/ML Systems, preparing an FDA submission Part III: ‘The submission’
Summary By the time teams reach the submission phase, the assumption is often that the hardest decisions are behind them.
Read more
May 13, 2026
AI/ML Systems, preparing an FDA submission Part II: ‘Pre-sub strategy’
Summary In Part II of this series, Leon shifts the focus from initial regulatory positioning to one of the most
Read more