In December 2025 the Medical Device Coordination Group (MDCG) published a guidance introducing the EU Breakthrough Devices framework, supporting earlier access to innovative medical devices and IVDs with significant clinical benefit. The framework offers a structured EU‑level process and access to scientific advice from expert panels for designated devices.
An online information session will take place on 24 April 2026 ahead of the Q2 2026 pilot launch, outlining key features of the framework and practical considerations for manufacturers and notified bodies. Don’t miss it!
