healthcare.digital December 19, 2025
The biggest European MedTech developments this week centre on the EU’s proposed overhaul of MDR/IVDR, a broader Commission health package to boost innovation and resilience, and continued capital formation for MedTech and digital health scale‑ups.
Together these moves signal a more innovation‑friendly regulatory path and fresh growth funding for European MedTech heading into 2026.
MDR/IVDR targeted revision
The European Commission has proposed a targeted simplification of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to make rules easier, faster and more effective while maintaining high patient safety.
MedTech Europe welcomed the proposal as a “long‑awaited and necessary step” to fix parts of the system that are not working for patients, innovators and providers, highlighting the need to...
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