Resources 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.

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.

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.

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.

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.

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.