Master EUDAMED Compliance — Get Our Two Guides

Two complementary references for medical device manufacturers preparing EUDAMED compliance.

Is This For You?

  • Medical device manufacturers preparing or maintaining EUDAMED registration
  • Regulatory affairs and quality teams (RA/QA, PRRC)
  • IT and IS leaders integrating regulatory systems with ERP/PLM/QMS
  • Decision-makers evaluating compliance
  • information system architecture

Get your free ressources now.

EUDAMED Practical Guide cover with medical device professionals discussing compliance strategies.
EUDAMED compliance guidebook for medical device manufacturers.

What You Will Find in Our Resources

Eudamed, from filling to active management

New: May 2026

  • The three pillars: UDI, MDR/IVDR, EUDAMED
  • Why fragmented product data is the main compliance risk
  • Three official EUDAMED synchronization mechanisms
  • Building a product regulatory repository
  • Multi-market reach: GUDID, Swissdamed, and beyond
  • From filing to active management

Eudamed, the Practical Guide

Over 10.000 Download yet

  • The 6 EUDAMED modules
  • Critical deadlines
  • UDI-DI fundamentals
  • Implementation paths
  • Special cases (legacy devices, SPPPs)
  • Data integrity (ALCOA+) requirements
Access Both Guides →

What You Will Learn

EUDAMED Fundamentals & Modules

Complete explanation of the 6 interconnected EUDAMED modules and how they work together to ensure regulatory compliance and device traceability.

Critical Deadlines & Timeline

Detailed registration timeline with key dates: January 1, 2026 for new devices and July 1, 2026 for existing devices, with class-specific transition periods.

UDI System Mastery

Technical understanding of UDI-DI and Basic UDI-DI identifiers, their differences, and when changes require new identifiers for your medical devices.

Implementation Strategies

Compare manual, semi-automated, and fully automated approaches to EUDAMED compliance based on your device portfolio size and organization resources.

Data Model & Integrity Requirements

Essential principles of ALCOA+ for data integrity and creating a robust data model that meets EUDAMED’s strict technical requirements.

Special Cases & Exceptions

Handling of “legacy devices,” systems, procedure packs, and other special cases with specific regulatory requirements in EUDAMED.

  • Why Trust Ackomas?

    • 20+ years of expertise in healthcare regulatory compliance
    • Direct collaboration with regulatory authorities
    • Specialized in data structuring for medical device manufacturers
    • Proven methodology used by leading manufacturers