New Guidance MDCG 2025-9: Accelerating Access to Breakthrough Medical Devices in Europe

The Medical Device Coordination Group (MDCG) has published its 2025-9 guidance on Breakthrough Devices (BtX) under the Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR).

Key highlights include:

• Faster market access for innovative medical devices and IVDs addressing unmet medical needs;
• Clear BtX designation criteria: high technological novelty and significant clinical impact for life-threatening or irreversibly debilitating conditions;
• Guidance on clinical data collection, combining pre-marketing data, PMS data, and post-market data (PMCF/PMPF);
• Enhanced collaboration between manufacturers, notified bodies, competent authorities, and expert panels;
• Support for innovation through EU and national funding mechanisms.

This guidance is a major step toward fostering innovation without compromising safety and performance, ensuring timely patient access to breakthrough technologies.

DOWNLOAD THE GUIDANCE MDCG 2025-9