Version 4 of the Manual on Borderline and Classification for Medical Devices was published in September by the European ...

What I am about to share with you is a guide to medical device regulatory classification. In this guide, I will provide you with a step-by-step approach for determining how your medical device will be ...

The European Commission, by its decision dated 26 November 2025, confirmed the functionality of four modules within the ...

Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a ...

The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic. According to the European Commission, the Medical Devices ...

The European Union has released two significant guideline changes to expand its medical device framework, updating the classification rules for medical device software to include app platform ...

Process AI in Medical Devices: What Works and What's Next, Upcoming Webinar Hosted by Xtalks ...