EU MedTech Innovation Pressure: What Professionals Need to Know (2025-2026)
The EU MedTech Innovation Pressure: Navigating 2024-2026 "Crunch" and EY-DG SANTE Findings For years, the European Union was the global "launchpad" for medical innovation. A "CE Mark" was often the first major milestone for a startup before tackling the FDA. However, the tide has turned. As we move deeper into the mid-2020s, the medical technology landscape is facing a pivotal identity crisis. The recent EY-DG SANTE study , commissioned by the European Commission, has provided the data to back up what many MedTech professionals have been whispering in boardrooms: the regulatory burden of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is creating an "innovation drain." The Data Speaks: Key Findings from the EY-DG SANTE Study The study was designed to monitor the availability of medical devices on the EU market. The results are a wake-up call. According to the data, a significant percentage of manufacturers—pa...