Since 28 May 2026, the EUDAMED UDI/Devices module has been mandatory to use. For applicable legacy devices that continue to be placed on the EU market, the transition period provides until 28 November 2026 to complete their registration in the UDI/Devices module.
The EMDN code you select, the manufacturer’s registration status and even the source of your certificate information can all affect the accuracy of the record. And when you are dealing with a large device portfolio, a small mistake repeated across multiple registrations can quickly turn into a lot of additional work.
So, before submitting your device data, here are four common mistakes worth checking.
1. Selecting the wrong EMDN code
An EMDN code might look like just another field to complete. But selecting a broad category instead of the appropriate terminal code can mean having to return to the registration and make corrections later.
Before submitting the record, check that EMDN code you have selected accurately reflects the device.
It is a small check at the beginning that can save additional work later.
2. Not checking the manufacturer’s SRN status
Device registration does not exist in isolation from actor registration. If the manufacturer’s actor information is not in order, this can create problems when you move on to registering the device.
Check that the manufacturer’s actor registration and Single Registration Number (SRN) are valid and that the relevant information is up to date before you start entering the device data.
3. Submitting the wrong UDI-DI level
Device identification is another area where getting the details right from the start matters.
Before preparing the registration, make sure you have correctly identified which information is required for the relevant device record. Confusing different identification levels can result in incorrect or inconsistent information being entered into EUDAMED.
And that means going back to correct it later.
4. Using certificate information from internal records
Your internal records might be the easiest place to find certificate information. That does not necessarily mean they should be your final reference.
Information stored internally can be outdated, incomplete or incorrectly transcribed. If that same information is then used for the EUDAMED registration, the inconsistency carries over with it.
Before entering certificate details, cross-check them against the official documentation issued by the relevant Notified Body.
Get Your Legacy Device Registration Right in EUDAMED
None of these checks is complicated on its own. The difficulty comes when the same issues appear across several devices or an entire portfolio and need to be corrected later.
With the 28 November 2026 transition deadline approaching, checking the information before registration can save time and unnecessary back-and-forth further down the line.
Feeling unsure about what your legacy devices need in EUDAMED? Reach out to our regulatory experts for guidance and support throughout your EUDAMED registration journey.
Preparing your legacy devices for EUDAMED? What part of the registration process is giving you the most trouble? Let us know in the comments.
References
European Commission. (2024). Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (Text with EEA relevance). Retrieved on 24/08/2026.
European Commission. (2026). UDI/Device registration. European Database on Medical Devices (EUDAMED). Retrieved on 24/08/2026.
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