
Master EUDAMED Compliance – Download Your Free 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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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."
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