Compliance Is Changing. Are You Ready?
The EU MDR (2017/745) and IVDR (2017/746) have redefined medical device compliance—and EUDAMED is at the center of this transformation. As enforcement tightens and new transition provisions under Regulation (EU) 2024/1860 take effect, manufacturers can no longer rely on manual or fragmented compliance approaches.
UDI registration and seamless data exchange are now critical to EU market access.
This whitepaper explains how EUDAMED works, why the UDI system is foundational to traceability and transparency, and how organizations can navigate manual, bulk, and machine to machine (M2M) data submissions with confidence.
Inside the Whitepaper
- What EUDAMED means for MDR & IVDR compliance
- The role of UDI in device identification and lifecycle tracking
- Manual vs. bulk vs. M2M submissions—requirements and risks
- Practical insights to prepare for evolving regulatory expectations
Regulations are evolving. Timelines are shifting. Digital readiness is non-negotiable.
This whitepaper helps you stay compliant, reduce risk, and future proof your EUDAMED strategy.
Download the whitepaper and stay ahead of EU regulatory change.