CTR NEWSFLASH
- 4 dec 2025
- 1 minuten om te lezen
🚨 Regulation Alert in the Research World! 🚨
Buckle up—Europe is moving full speed ahead!
🔹 CTR NEWSFLASH
FAST-EU is here, marking a major leap toward faster, more coordinated trial assessments across Europe. Translation:
➡️ quicker study start-ups,
➡️ smoother review processes,
➡️ bringing innovative therapies to patients sooner.
With Europe’s optimized timelines, highly engaged sites, and Ad Hoc Clinical's excellent support during start-up and monitoring, there’s never been a better moment to accelerate your clinical trials in our regions!
Our study start-up experts are fully ready to guide you through every step of your EU trial journey.
Great to see France and Belgium once again driving meaningful progress in clinical research.
Articles from the respective authorities are linked in the comments!
🔹 MDR NEWSFLASH
The European Commission announced a couple of days ago that 4 Eudamed modules are now officially functional, kicking off a six-month transition toward mandatory use (effective 28 May 2026).
In research world, we’re still eagerly awaiting the two modules that matter most for our sector:
🔸 Post-Market Surveillance & Vigilance Module – audit planned next year; expected functional in Q4 2026, mandatory by Q2 2027.
🔸 Clinical Investigation & Performance Studies Module – still in development; audit currently estimated for Q2 2027.
Progress is happening and in the meantime, our team continues to drive your investigation and performance submissions seamlessly through all current local systems.
Many thanks to the European Commission for yesterday’s insightful and enlightening EUDAMED workshop!
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