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EUDAMED UDI/Device registration deadline

09/11/2026 Regulatory news

By 28 November 2026, manufacturers must use the UDI/Device module in EUDAMED to register devices placed on the EU market before 28 May 2026. This includes MDR, IVDR and legacy devices. 

The deadline follows the introduction of mandatory EUDAMED registration on 28 May 2026 for devices being placed on the market for the first time. 

What devices must be registered?

Manufacturers who placed devices and IVDs on the market before 28 May 2026, and continue to place them on the market, must register these devices. This includes:

  • MDR devices
  • IVDR devices
  • Legacy devices sold with MDD, AIMDD or IVDD certificates

How and when do I register?

Registration must be completed by 28 November 2026 through the EUDAMED UDI/Device module. For more information about using EUDAMED, visit the EUDAMED Information Centre.

Why do I need to register?

Registration is required to:

  • Meet manufacturer obligations under the EU medical device regulations 
  • Improve the identification and traceability of medical devices
  • Support access to medical device information
  • Ensure up to date device information on EUDAMED