EUDAMED Articles & Resources for Medical Device Manufacturers
Regulatory Intelligence
Stay ahead of the milestones and turn MDR/IVDR obligations into competitive edge. Our practical deep-dives guide you step by step, from UDI-DI preparation to machine-to-machine declarations in EUDAMED.
The Benefits of EUDAMED for Manufacturers: Beyond Compliance
EUDAMED is more than a compliance checkbox. By standardising data, boosting product visibility and enabling proactive vigilance, the database can streamline processes, cut costs and sharpen competitive edge. This article shows manufacturers how turning regulatory obligations into operational wins can power digital transformation and strengthen market positioning across Europe.
Differences Between EUDAMED and GUDID: What Manufacturers Need to Know
EUDAMED and GUDID both aim to strengthen device traceability, yet they differ sharply in scope, structure and terminology. This article compares Europe’s six-module, Basic UDI-DI-centric database with the FDA’s UDI-focused GUDID, outlining the practical implications—and compliance pitfalls—for manufacturers selling into both regions.
The Complete EUDAMED 2025–2026 Compliance Timeline
EUDAMED is moving from voluntary to mandatory: Regulation (EU) 2024/1860 locks in 2025–2026 deadlines. This concise timeline explains what changes, who is affected and when—so manufacturers, authorised representatives and importers can prioritise registrations, deploy M2M connections, report supply disruptions on time and maintain EU market access.
The 6 EUDAMED Modules — Clearly Explained
EUDAMED’s six linked modules create one EU hub for device traceability—critical knowledge for manufacturers ahead of the 2026 compliance deadline.
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