The EUDAMED will be mandatory to use as from 28 May 2026

The Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices declaring the functionality of the first four modules has been published in the Official Journal of the European Union (OJEU)  of 27 November 2025. 

In accordance with the transitional provisions set out in Regulation (EU) 2024/1860, this publication triggers a transition period of 6 months; 

Therefore, as from 28 May 2026 the first four EUDAMED modules will be mandatory to use: 

• Actor registration
• UDI/Devices registration
• Notified Bodies & Certificates
• Market Surveillance

Timeline is given below:

• All economic operators (EU and non-EU manufacturers, authorized representatives, system/procedure pack producers and importers) must ensure they are registered into Actor Registration Module before 28.05.2026 and possess a valid Single Registration Number (SRN), which is required for all other entries.
• MDR-certified devices have 6-month transition period to register in the UDI module, which means registration must be completed before 28.05.2026,
• Legacy devices have 12-month transition period to upload master data, which means registration must be completed before 28.11.2026.

After these deadlines, unregistered economic operators will not be able to operate and non-compliant products will no longer be placed on the market. Enforcement actions such as sales bans, recalls, and fines will follow.