What happens if incorrect information has been entered during device registration and EUDAMED does not allow the information to be corrected directly?
Fortunately, this situation is easier to fix than many manufacturers expect.
The Common Misconception: “Once Submitted, It Cannot Be Changed”
In most cases, information entered EUDAMED can be updated and corrected. When changes must be made, the system allows you to create a new version of the registration whilst keeping a record of the previous versions. In simple terms: manufacturers can always access the history of their device registrations.
On the other hand, there may be situations where a specific piece of information cannot be corrected through a standard update.
How EUDAMED Handles Corrections
In these specific cases, EUDAMED provides a discard function. This function allows you to deactivate instead of deleting the registration. Once discarded, the registration can no longer be visible in public, but it remains accessible in the system history for the manufacturer, competent authorities and notified bodies.
In short, if you entered the wrong information in EUDAMED, don’t panic. EUDAMED includes mechanisms to correct, or when necessary, deactivate and replace inaccurate registrations.
Why EUDAMED Data Management Matters
As of 28 May 2026, the Actors, UDI/Devices, Notified Bodies & Certificates and Market Surveillance modules of EUDAMED are now mandatory under the MDR and IVDR. With EUDAMED now serving as a cornerstone of the European medical device regulatory system, accurate registrations and data management have never been more important for manufacturers and economic operators.
As with any large regulatory database, mistakes can happen. The good news is that EUDAMED has been designed with mechanisms that allow manufacturers to update and correct information when needed. Knowing how these processes work can save valuable time and prevent unnecessary compliance concerns down the line.
What Challenges Have You Faced with EUDAMED?
Have you already encountered challenges when updating device registrations? Have you needed to use the discard function? Share your experience in the comments, we’re interested to hear how manufacturers are navigating these new requirements.
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