healthcare.digital January 3, 2026
European MedTech this week is shaped by three themes: MDR/IVDR simplification and EUDAMED timing, new guidance for Notified Bodies, and a steady drumbeat of innovation and capital around robotics, neuro and data‑rich devices.
Regulatory and guidance moves
The Commission’s December 2025 proposal to “simplify” MDR/IVDR is setting the 2026 agenda, with a strong focus on digitalising procedures, harmonising Notified Body practices, and clarifying rules for AI‑enabled devices and nano materials.
A draft implementing regulation on how Notified Bodies run conformity assessments for devices and IVDs is out to consultation until 9 January 2026, signalling tighter but more predictable oversight across the EU.
EUDAMED and transparency in 2026
The Commission’s late‑2025 notice that four EUDAMED modules are now fully functional starts...
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