Master EUDAMED Compliance – Download Your Guide Today!

The essential guide to simplify MDR & IVDR compliance for medical device manufacturers

  • Complete explanation of the 6 EUDAMED modules
  • Registration obligations and deadlines (January 1, 2026 for new devices, July 1, 2026 for existing devices)
  • Technical details on UDI-DI and Basic UDI-DI identifiers
  • Differences between manual and automated compliance approaches

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🔒 Our Commitment

ACKOMAS will never share your data with anyone outside the company—for marketing or any other purpose. 100% GDPR compliant.

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.

  • Is This Guide for You?

    • Medical device manufacturers required to register in EUDAMED
    • Regulatory affairs professionals managing MDR/IVDR compliance
    • Quality system managers implementing data integrity processes
    • IT specialists integrating systems with EUDAMED
    • System/Procedure Pack Producers (SPPPs)
    • Decision-makers evaluating compliance approaches

    "EUDAMED requires a clear governance strategy as it integrates across multiple regulatory modules with strict data integrity requirements."