EUDAMED is being rolled out in modules. Since May 28, 2026, use of the actor registration, UDI and device registration, notified bodies and certificates, and market surveillance modules has been mandatory, so new devices must be registered before they are placed on the EU market. Devices already on the market, including legacy devices, have until November 27, 2026 to be registered.

Why it matters for labeling

The data registered, such as the UDI-DI, device name and model, and authorized representative, has to match what is printed on the device and its packaging. Much of it is publicly visible, so a mismatch can be seen by regulators and customers. A label change that affects registered data means an update in EUDAMED too.

Common mistakes

  • Registering devices without checking the label data against the record
  • Updating the label but not the registration
  • Assuming EUDAMED covers Switzerland, which has its own database
  • Missing the deadline for devices already on the market

Sources