28 May 2026 was a major milestone for EUDAMED. However, it was not the last important date in the 2026 EUDAMED transition.
Following the mandatory use of four EUDAMED modules in May, manufacturers and other economic operators have already entered a new phase of the EUDAMED rollout.
The next key date is 28 November 2026, when the focus turns to the registration of legacy devices.
For manufacturers managing portfolios that include devices placed on the market under the transitional provisions of the MDR or IVDR, this deadline requires attention now, not in November.
Legacy device registration works differently
Manufacturers already familiar with registering MDR and IVDR devices should not assume that legacy devices follow exactly the same registration process.
One important difference concerns device identification.
Legacy devices do not use the same Basic UDI-DI approach as devices registered under the MDR and IVDR. Instead, EUDAMED provides specific identifiers for legacy-device records, including the EUDAMED-DI, to represent these devices within the database.
On its own, this may seem like a relatively small technical difference. However, for manufacturers with multiple legacy devices, registrations can quickly become more complex.
Device identification, classification, certificate information and economic operator details all need to be considered and, where applicable, aligned.
This is where preparation becomes important.
28 November is closer than it seems
The November deadline should not be viewed as the date to start preparing.
Before a legacy device can be correctly registered, manufacturers may need to review existing information, identify the devices concerned, verify identifiers and check that the information held across different regulatory records is consistent.
For larger portfolios, this can take considerable time.
An inconsistency between device information and certification records, for example, may require additional investigation before the relevant information can be submitted or corrected. Economic operator information may also need to be reviewed to ensure that the relevant records are complete and up to date.
Waiting until the final weeks can therefore leave little room to identify and resolve unexpected issues.
What happens if the required registration is not completed?
The fact that a legacy device may continue to benefit from applicable MDR or IVDR transitional provisions does not mean that its EUDAMED obligations can simply be postponed.
Once the relevant requirements apply, manufacturers need to ensure that the necessary records are in place and that the information submitted is accurate and complete.
Incomplete or inconsistent information can create more than an administrative inconvenience. Manufacturers may need to resolve discrepancies between device information, certificates and economic operator records. Importers and distributors may also be affected where the information they rely on is incomplete or inconsistent.
Where non-compliance is identified, further action may follow under the applicable MDR or IVDR requirements and national legislation.
The practical message is simple: the closer 28 November gets, the less time manufacturers have to resolve problems before they become time-critical.
Is your legacy-device portfolio ready?
With the deadline approaching, manufacturers should consider reviewing their portfolio now.
For example:
- Do you know which legacy devices are affected by the upcoming requirements?
- Have the relevant legacy-device identifiers been established correctly?
- Is your device information consistent with your certificates and other regulatory records?
- Are your manufacturer and economic operator details complete and up to date?
- Have potential discrepancies been identified and addressed?
Do you have sufficient time to resolve any issues before 28 November?
If some of these questions are difficult to answer, it may be worth reviewing your EUDAMED readiness before the deadline becomes urgent.
How Obelis can support your EUDAMED compliance
For many manufacturers, the challenge is not simply entering information into EUDAMED. It is making sure that the information being submitted is complete, accurate and consistent across the relevant regulatory records.
Obelis supports EU and non-EU manufacturers and other economic operators with EUDAMED compliance, including actor registration, Single Registration Number (SRN) support and device-data registration under the applicable MDR and IVDR requirements.
Our regulatory team can help manufacturers assess their current status, identify potential gaps and support the registration process, helping reduce the risk of last-minute issues.
Preparing early gives you time to identify what is missing, resolve inconsistencies and complete the necessary registrations before 28 November 2026.
If you are unsure whether your legacy-device portfolio is ready for the upcoming EUDAMED requirements, speak with our regulatory experts to assess what needs to be completed before the deadline.
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.
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