EUDAMED : Prepare for Mandatory Implementation

EUDAMED becomes mandatory on 28 May 2026, with four modules now declared fully functional by the European Commission. This marks a decisive step toward a more structured, transparent, and traceable regulatory ecosystem for medical devices across the EU.

Our brochure “EUDAMED Explained: Prepare for Mandatory Implementation” offers a clear and accessible overview to help all stakeholders prepare for this transition.

What’s Inside the Brochure

• Overview of the four mandatory modules: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, Market Surveillance
• Responsibilities of manufacturers, economic operators, and notified bodies
• Key timelines, including phased obligations for certificate registration
• Practical insights on data accuracy, process alignment, and regulatory expectations
• Introduction to GMED Connect, including GC Client and GC License, supporting efficient and aligned EUDAMED data management

Why This Matters

EUDAMED strengthens data structure, transparency, and traceability across the EU.
Preparing early is essential to avoid bottlenecks and ensure smooth compliance, especially as accuracy and consistency of submitted data become central regulatory requirements.

Access the essential information you need to prepare confidently for the mandatory EUDAMED implementation, Download the Brochure