Understanding the CE Marking Challenges of LLM-based Medical Devices
Nov 25, 2025 | 3:00 PM - 3:10 PMStartup Stage
Nov 25, 2025 | 3:00 PM - 3:10 PM
Startup Stage
Description
Large Language Models (LLMs) are increasingly used to power clinical decision support and healthcare professional recommendation systems. Turning these technologies into compliant medical devices raises complex regulatory challenges. This session will unpack the CE marking journey for LLM-based Medical Devices, guiding innovators from tech concept to regulatory compliance under the EU MDR (2017/745) and the AI Act.
