EUDAMED: What manufacturers need to know now

EUDAMED Explained: What Manufacturers Need to Know

‍

In this recorded presentation, regulatory affairs specialist Giulia Guerreschi delivers a clear, practical explanation of EUDAMED, the European Commission’s centralized database for medical and IVDs. Developed under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), EUDAMED is becoming a foundational requirement for any manufacturer selling into the European Union.

‍

This session was designed for regulatory professionals, manufacturers, and authorized representatives who need to understand how EUDAMED works, what’s required to comply, and why preparation can’t be delayed. With the European Commission confirming that multiple EUDAMED modules will become mandatory by Q3 2026, the clock is ticking. Giulia explains how the system is structured, what’s functional today, and what manufacturers need to do right now to ensure smooth compliance and uninterrupted market access.

‍

Topics covered include:

‍

• What is EUDAMED and why was it created?
  Learn how EUDAMED consolidates disparate national databases into a single, harmonized system that improves device traceability, transparency, and communication across the EU market.
• The six EUDAMED modules, explained:
  Gain clarity on the function and status of each module, from Actor Registration and UDI/Device Registration to Notified Body Certificates, Clinical Investigations, Vigilance, and Market Surveillance.
• Who is responsible for what?
  Understand the specific obligations for manufacturers, notified bodies, and other economic operators, and how those roles are changing under the new regulatory structure.
• How to register and navigate the system:
  Step-by-step guidance on how manufacturers can get started, including how to obtain a Single Registration Number (SRN), create an EU login, and assign users within your organization.
• Why data quality matters:
  Discover how poor data entry can create regulatory and reputational risk, and why accuracy, traceability, and timely updates are essential in a public-facing system.
• What happens next:
  A forward-looking view of how EUDAMED will evolve, what deadlines matter most, and how the transition away from national databases will affect your go-to-market strategy in the EU.

‍

Whether you're just starting your EUDAMED journey or looking to optimize your registration strategy, this session delivers actionable insights and expert clarity. For companies seeking additional support, Pure Global offers hands-on guidance to help navigate every phase of EUDAMED registration and compliance.

‍