EUDAMED Milestone: Mandatory Modules from 28. May 2026

Date

December 2, 2025

Category

EU Regulations

Description

On 27 November 2025, the European Commission officially announced that the first four modules of the European Database on Medical Devices (EUDAMED) are fully operational and meet the required specifications. With the publication of Commission Decision (EU) 2025/2371 in the Official Journal of the EU, a six-month transition period begins. Starting 28 May 2026, the use of these modules will be mandatory for all relevant economic operators (EUDAMED Modules Timeline – November 2025).

Which modules are affected?

Actor Registration
UDI/Device Registration
Notified Bodies & Certificates
Market Surveillance

This mandatory implementation marks a significant step toward greater transparency, traceability, and regulatory compliance in the European medical device market. Manufacturers, importers, and authorized representatives must ensure their processes and data are updated in time. For products already on the market before 28 May 2026, an additional deadline applies: 27 November 2026 for registration in the UDI module.

What does this mean for the medical device industry?

The mandatory use of EUDAMED modules is a milestone in the implementation of MDR/IVDR requirements. Companies should review their internal processes now and take the necessary steps for registration to avoid delays or compliance risks.

Do you have questions or need support with implementation?

We offer expert guidance on process design, product and economic operator registration, and data preparation to ensure a smooth EUDAMED upload.

Our experts provide reliable support, including process design, accurate registration of your products and economic operators, and data preparation for seamless uploading to EUDAMED.