Commission Decision (EU) 2025/2371 confirms that the four core modules of the EUDAMED database are now operational and the mandatory transition period for MDR and IVDR obligations has begun. Starting May 28, 2026, manufacturers must submit complete and consistent product-related information to the European Database on Medical Devices (EUDAMED). Since EUDAMED data is closely linked to documents such as IFUs, labels, and certificates, even minor discrepancies in terminology or translations can result in regulatory objections. Inspectors expect harmonized data and documents across all markets – a challenge that many companies must now address systematically and methodically.
What Does Commission Decision (EU) 2025/2371 on EUDAMED Regulate?
With six recitals and two articles, Commission Decision (EU) 2025/2371, appears surprisingly concise at first glance. In fact, however, it has far-reaching consequences, as it officially confirms the operational readiness of the four core modules of the EUDAMED database and so marks the start of mandatory use by manufacturers.
Manufacturers, importers, and authorized representatives must apply for a unique Single Registration Number (SRN). This provides the basis for all further activities in the medical device database and ensures clear identification.
Each product must be entered with complete UDI and device information. Changes to the intended purpose, risk class, model name or other data must be updated consistently and promptly.
This module significantly increases transparency and traceability: certificates, assessments, and the status of documents are fully digitized.
Vigilance reports, safety reports, and post-marketing surveillance (PMS) activities will now be handled centrally via EUDAMED. This makes surveillance easier for authorities and establishes a standardized reporting system across the EU.
EUDAMED’s functionality has been verified based on an independent audit – a formal milestone in the transition to full implementation of the MDR and IVDR. For manufacturers, this means that Regulatory Affairs, Quality Management, and Language Management must work more closely together to ensure that data is consistently, accurately, and correctly translated across all systems.
EUDAMED and Translations
The mandatory use of EUDAMED increases the need for linguistic precision. The platform is not merely a registry, but a regulatory system in which all data records must match the associated documents exactly. “Acceptable variants” of a name are now a thing of the past. Without accurate, consistent translations, registrations and market access are at risk. At the same time, language requirements vary across the EU, increasing the risk of inaccurate or inconsistent translations if terminology is not properly managed.
How mt-g Can Support Manufacturers Today
To help companies confidently meet the new EUDAMED requirements, mt‑g offers comprehensive end-to-end support for the language and data process. This includes in-depth consulting on matters relating to the MDR and EUDAMED as well as the joint development of a customized data and translation strategy. Defining and maintaining consistent terminology is pivotal here, as it provides a mandatory foundation for all markets. mt‑g produces MDR-compliant translations, manages your terminology, and on request, cleans up existing translation memories to ensure consistent, compliant, audit-ready translations in all EU languages.
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