Start here — a 3-step reading path
NEW TO EUDAMED COMPLIANCE?
Not sure where to begin?
Follow these three steps to go from understanding EUDAMED
to taking action.
What is EUDAMED and why it matters?
Step 1
Get a clear overview of the 6 EUDAMED modules, who needs to register, and what data is required from medical device manufacturers.
Key deadlines & requirements
Understand the registration timeline — January 2026 for new devices, July 2026 for existing ones — and what your RA/QA team needs to have ready.
Step 2
Download the EUDAMED Guide
A complete, actionable guide covering all 6 modules, UDI identifiers, and implementation strategies — from manual to fully automated.
Step 3
Articles & Webinar Replays
Browse our full collection of regulatory resources. Each one covers a specific aspect of EUDAMED, GUDID, UDI, or medical device data governance.
EXPLORE OUR LIBRARY
EUDAMED Exclusive Client Reveal: How Santex Spa Secured MDR Compliance
Santex S.p.A. shares how they achieved MDR and EUDAMED compliance with ACKOMAS. A 30-minute live…
GUDID at the Heart of the FDA Framework: In-Depth Analysis
The FDA's updated Compliance Program 7382.850 (February 2026) formally establishes GUDID as an inspectable, mandatory…
EUDAMED 2026 : passer en production en toute confiance
L’entrée en application progressive des modules EUDAMED marque une étape clé pour les fabricants de…
EUDAMED A Synthesis for 2025 and the Roadmap to 2026
This guide outlines the mandatory transition to EUDAMED compliance triggered by Commission Decision (EU) 2025/2371.…
Legacy Devices under EUDAMED: Obligations and Exceptions
This guide explains the regulatory requirements for legacy medical devices — those CE-marked under older…
FAQs
Find answers to the most common questions about EUDAMED, GUDID, and UDI compliance.
What is EUDAMED and why is it important for medical device manufacturers?
EUDAMED (European Database on Medical Devices) is the official EU database for medical devices under the MDR and IVDR regulations. It connects six modules — actor registration, UDI/device registration, notified bodies, certificates, clinical investigations, and vigilance. All manufacturers placing devices on the EU market must register their devices in EUDAMED. The deadline is January 1, 2026 for new devices and July 1, 2026 for existing devices.
What is the difference between GUDID and EUDAMED?
GUDID (Global Unique Device Identification Database) is the FDA’s database for medical devices sold in the United States, while EUDAMED serves the European Union. Both require UDI (Unique Device Identification) data, but their data models, submission formats, and regulatory requirements differ. Manufacturers selling in both markets must maintain compliance with both systems — which is where data synchronization becomes critical.
What is UDI and how does it affect my compliance obligations?
UDI (Unique Device Identification) is a standardized system to identify medical devices through their lifecycle. It consists of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier). UDI
data must be submitted to EUDAMED (EU) and/or GUDID (US) depending on your markets. Changes to device characteristics may require new identifiers, making ongoing data management essential.Can I manage EUDAMED and GUDID compliance manually?
For small portfolios (under 50 devices), manual submission is possible but time-consuming and error-prone. As your portfolio grows, the risk of data inconsistencies increases significantly.
Semi-automated or fully automated approaches — such as the ACKOMAS platform — reduce errors, ensure real-time synchronization, and free your RA/QA team to focus on strategic compliance tasks.What are the key EUDAMED registration deadlines?
Under the current timeline, manufacturers must register new medical devices in EUDAMED by January 1, 2026, and existing devices by July 1, 2026. Class-specific transition periods may apply. Staying
ahead of these deadlines is critical to avoid market access disruptions.How can I stay updated on regulatory changes affecting medical devices?
ACKOMAS publishes regular articles and webinar replays covering EUDAMED, GUDID, UDI, and broader medical device data governance topics. You can also subscribe to our newsletter for concise regulatory updates delivered to your inbox — no noise, only actionable changes and upcoming deadlines.
Turn compliance knowledge into action
Discover how ACKOMAS automates EUDAMED, GUDID & UDI data synchronization — so your RA/QA team stays compliant without the manual work.
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Webinar replays & regulatory briefings
Watch recorded sessions on EUDAMED registration, UDI structuring, and data governance
Deadline alerts & regulatory changes
Be notified when EUDAMED deadlines, MDCG guidance, or submission rules change
Compliance guidance for your team
Practical resources to prepare for audits, structure your UDI data, and manage multi-market registration