🚨 Today marks the first official EUDAMED deadline, reinforcing a critical shift.
EUDAMED registration is now mandatory for new devices entering the EU market.
This is not just a regulatory milestone — it directly impacts how manufacturers plan and execute market access under MDR/IVDR.
💡 How MDSS Supports You
We go beyond advisory — we integrate EUDAMED into your project execution:
- EC REP services with built-in EUDAMED verification
- End-to-end device registration readiness support
- UDI and data structuring strategies
🚨 Important:
If MDSS acts as your European Authorised Representative (EC REP), EUDAMED verification will now be an integrated part of your onboarding and submission projects.
📌 What This Means in Practice
For new devices, EUDAMED is no longer optional:
- Device registration in EUDAMED will be required
- UDI and structured device data must be prepared upfront
- Actor registration (SRN) must already be in place
⚠️ What We’re Seeing Across the Industry
Many companies are still underestimating:
- The level of data structuring required
- The link between UDI, EUDAMED, and technical documentation
- The need for early preparation during product development
📣 Let’s Talk
📅 Book a meeting with our experts 🌐 Learn more about our services
EUDAMED is no longer “upcoming” — it is operational and shaping market access today.
Organizations that integrate it early into their processes will move faster, with fewer regulatory obstacles and stronger compliance confidence.
