Latest Blog Posts
Navigating MDR: Fresh Insights and Updates
MDR & IVDR Regulatory Post-Market Complexities
Summary The MDR and IVDR have significantly changed the regulatory landscape for medical devices in Europe, extending responsibilities and liabilities across the entire Economic Operator
Large Language Models (LLMs) in Healthcare: A European Perspective
Summary Large Language Models (LLMs) are rapidly reshaping healthcare, supporting everything from administrative efficiency to clinical workflows. While their adoption continues to grow, one question
Implications of the EHDS regulation for SaMD’s and AI/ML-enabled Medical Devices
Summary The European Health Data Space (EHDS) Regulation represents a significant step towards creating a more connected and interoperable healthcare ecosystem across Europe. While much
When does healthcare AI fall under the EU AI Act?
An overview of the first episode of NEN’s podcast on AI in healthcare AI keeps turning up across everyday care, from ChatGPT in a client
The EU Commission’s proposed implications on SaMD and AI-enabled devices
Summary The EU Commission SaMD proposal introduces significant changes that could reshape the regulatory landscape for Software as a Medical Device and AI-enabled medical devices
Third-Party LLMs in Medical Devices – QMS implications
Summary Medical Device QMS requirements are evolving as third-party large language models (LLMs) become part of AI-enabled medical devices. While these models can accelerate innovation
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 measures to simplify the regulatory
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 those developing Software as a
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 auditing management systems and analysing
