EU strengthens its support for breakthrough medical technologies

The Medical Device Coordination Group (MDCG) has published guidance MDCG 2025-9 to streamline the pathway for breakthrough devices (BtX) under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This guidance aims to facilitate timely patient access to innovative technologies without compromising safety and performance requirements. It provides detailed recommendations on designation criteria, regulatory benefits, clinical evidence strategies, and post-market obligations. The document also clarifies roles of expert panels, notified bodies, and funding opportunities for manufacturers.

The new MDCG 2025-9 guidance is a major step toward enabling innovative medical devices and IVDs to reach patients faster – while maintaining strong safety and performance standards.

Read the full summary of the key takeaways, including designation criteria, the role of expert panels, evidence expectations, and what this means for manufacturers navigating the MDR/IVDR: Breakthrough devices: Key insights from MDCG 2025-9 guidance

At Aurevia, our experts can help you navigate these processes and ensure compliance with MDR and IVDR requirements. Contact us to learn more.