Mandatory Use of EUDAMED modules for medical devices

Mandatory use of four EUDAMED modules for medical devices begins on 28 May 2026.

This follows the Commission's publication of the functionalities of the four EUDAMED modules in the Official Journal of the European Union in November 2025.  

• Actor registration 

• UDI/Device Registration  

• Notified bodies and certificates  

• Market surveillance 

Relevant information for EUDAMED registration is available via our website section on Registration requirements for medical device economic operators. Key points from this information are highlighted here as a reminder.  

Transition periods

The table below outlines where transition periods are applicable

What should I do before 28 May 2026?

• Complete registration in the Actor module if you are a manufacturer, authorised representative, importer or a system and procedure pack producer.  

• Register MDR/IVDR devices placed on the market on or after 28 May. You must register before the first unit is placed on the market. Use the UDI/Device module to register. There is no transition period for these devices. 

What should I do before 28 November 2026?

• Register legacy devices and MDR/IVDR placed on the market before 28 May. Use the UDI/Device module to register. 

How to prepare?

Visit the European Commission Getting Ready for EUDAMED website for information and training for all actors to prepare for EUDAMED.