Since 28 May 2026, the use of the first four EUDAMED modules has become officially mandatory:

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

This marks a new phase of regulatory compliance for all economic operators in the European medical device industry. Particular attention should be paid to the UDI/Devices module, as the applicable requirements and registration deadlines vary significantly depending on the status of the device.

 

Our New Decision Support Tool for Manufacturers

To help you comply with the new requirements, we have made an interactive EUDAMED product registration decision support tool available on our website.

The tool enables you to quickly determine:

• Whether your device must be registered in the UDI/Devices module.
• By which deadline the registration must be completed.
• Which specific requirements apply to OLD DEVICES, LEGACY DEVICES, and MDR/IVDR-compliant devices.

Use the Decision Guide EUDAMED device registration on our website to assess your registration obligations quickly and easily.