Legacy and MDR/IVDR devices placed on the market before 28 May 2026 must be registered within weeks.
The EUDAMED Device Registration Deadline
On 28 November 2026, the transition period for registering existing devices in EUDAMED came to an end. Any device first placed on the EU market before 28 May 2026 that continues to be placed on the market must, by this date, be registered in the UDI/Device module. The obligation also covers legacy devices.
With only five weeks left, manufacturers should check now that their device data are complete, accurate and submitted on time.
Obelis explains what the deadline covers, what to prioritise now, and the details that most often cause last-minute delays.
EUDAMED’s Gradual Roll-Out
Regulation (EU) 2024/1860 changed how EUDAMED becomes mandatory. Instead of waiting for all six modules to be declared functional, each module now becomes mandatory six months after the Commission publishes a notice in the Official Journal of the EU (OJEU) confirming that it is functional.
The first notice came with Commission Decision (EU) 2025/2371 of 26 November 2025, published in the OJEU on 27 November 2025. It declared the first four modules functional. As a result, since 28 May 2026 the following modules have been mandatory to use:
- Actor registration
- UDI/Device registration
- Notified Bodies & Certificates
- Market Surveillance (used by competent authorities and the Commission)
Key dates at a glance
| Date | What happens |
|---|---|
| 27 November 2025 | Commission Decision (EU) 2025/2371 published in the OJEU, starting the clock |
| 28 May 2026 | Mandatory use of the first four modules; new devices must be registered before their first unit is placed on the market |
| 28 November 2026 | Deadline to register devices placed on the market before 28 May 2026 that continue to be placed on the market |
| 28 May 2027 | Deadline for notified bodies to register MDR/IVDR certificates issued before 28 May 2026 |
What Exactly Is Due by 28 November 2026?
The November deadline is a transition period for devices that were already on the market when EUDAMED became mandatory. According to the Commission’s Q&A on the gradual roll-out, it applies where:
- the first unit of a legacy device or an MDR/IVDR (“Regulation”) device, or a system or procedure pack, with a given device identifier was placed on the EU market before 28 May 2026, and
- further units with the same identifier continue to be placed on the market on or after that date.
For these devices, registration must be completed within 12 months of the OJEU notice. The Commission’s transition timeline sets this deadline at 28 November 2026.
Which devices do not need to be registered?
- Discontinued devices. Legacy and Regulation devices with no units placed on the market from 28 May 2026 do not need registration, unless a post-market surveillance or vigilance action (such as a serious incident report or FSCA) arises.
- Legacy devices already covered by “the same” Regulation device. If the MDR/IVDR version is registered and shares the same identification (for example UDI-DI, catalogue number or trade name), the legacy version does not need its own registration. If a vigilance action concerns the legacy device itself, it must exceptionally be registered.
- Custom-made, investigational and performance-study devices, which are not registered in the UDI/Device module.
Practical tip: because the 12-month period runs from the 27 November 2025, treat 27 November as your internal cut-off, and plan to submit well before it.
Your Pre-Deadline Checklist: What to Focus on Now
- Confirm your actor registration and SRN. Device registration is impossible without actor registration. All actors need a Single Registration Number (SRN).
- Map your full EU portfolio. List every UDI-DI, catalogue number and trade name sold in the EU, then sort each one into a category:
- placed on the market since 28 May 2026 (should already be registered before first placing);
- on the market before 28 May 2026 and still sold (the November deadline);
- discontinued before 28 May 2026 (no registration unless a vigilance action arises);
- legacy devices whose “same” Regulation device is already registered.
- Assign the right identifiers. MDR/IVDR devices need a Basic UDI-DI and UDI-DI. Legacy devices are not subject to UDI rules, so EUDAMED uses a EUDAMED DI (in place of the Basic UDI-DI) and a EUDAMED ID. Where a legacy device already has a UDI-DI, EUDAMED can generate the EUDAMED DI from it.
- Collect and validate device data. Gather risk class, EMDN code, trade name, intended use attributes and certificate references. Every field must match your technical documentation, labelling, instructions for use and notified body certificates.
- Choose your data-exchange route. EUDAMED offers three options: the web user interface, XML bulk upload, and machine-to-machine (M2M) exchange through an Access Point. The EUDAMED Information Centre suggests the interface for up to around 100 devices and bulk upload for roughly 100 to 1,000. Above 1,000 devices, it recommends M2M. Note that M2M access requires onboarding and testing in the EUDAMED Playground environment first, so it is rarely a quick fix this close to the deadline. Test XML files before your final submission.
- Coordinate with your notified body. Notified bodies can only link certificates to devices you have registered. Registering early helps them meet their own deadline of 28 May 2027 for pre-existing MDR/IVDR certificates.
- Build in a buffer. Validation errors, missing mandate confirmations and data corrections all take time. Aim to finish submissions by mid-November.
- Embed EUDAMED in your QMS. Assign clear ownership, add “register before first placing” to your launch process, and update records whenever device data changes.
Key Details That Often Cause Delays
Non-EU manufacturers and the Authorised Representative mandate
For non-EU manufacturers, each device registration must name an EU Authorised Representative with an active mandate in EUDAMED. EUDAMED retrieves the representative automatically only when one active mandate exists, as the Information Centre guide on legacy device registration shows. If you plan to change your Authorised Representative, complete the switch and mandate confirmation before you start registering devices.
Importers and distributors
Importers must hold their own actor registration, but registering devices remains the manufacturer’s responsibility. Distributors do not register in EUDAMED, although national registration rules may still apply to them.
Data consistency
EUDAMED data is cross-checked by notified bodies and competent authorities, and much of it becomes public. A mismatch between your EUDAMED entry, label and certificate is a compliance finding waiting to happen.
What if you miss the deadline?
After 28 November 2026, placing units of an unregistered device on the EU market means failing the registration obligation under Article 29 MDR or Article 26 IVDR. A valid CE certificate does not replace it, and competent authorities can take corrective measures.
What Comes After November?
- 28 May 2027: certificate registration deadline. Notified bodies must enter information on all MDR and IVDR certificates issued before 28 May 2026, for devices that are registered in EUDAMED or required to be. Only the latest version of each certificate and the latest related decision need to be entered.
- Vigilance and Post-Market Surveillance module. According to the Commission’s EUDAMED overview, this module is still in development. It will not go through a voluntary phase. It will become mandatory six months after the Commission publishes a notice in the Official Journal (OJEU) confirming that it is functional. Until then, vigilance reporting continues through national procedures.
- Clinical Investigations and Performance Studies module. This module is still under analysis. Like the vigilance module, it will have no voluntary phase and will become mandatory six months after its own OJEU notice.
Once the Vigilance module is live, even discontinued devices will need a UDI/Device registration, plus an actor registration, before a serious incident or FSCA can be reported. Keeping your actor and device data in order now will make that next step much easier.
How Obelis Can Help You Meet the Deadline
The 28 November 2026 deadline leaves little room for error, especially for manufacturers with large or mixed portfolios of legacy and MDR/IVDR devices.
As your EU Authorised Representative, Obelis can support you with:
- verifying your actor registration. Importantly, the authorised representative must approve your actor registration before the actor registration reaches the competent authority for final check and approval.
- assess your portfolio to identify exactly which devices must be registered by November;
- preparing and checking device data for consistency with your labelling and certificates;
- completing your EUDAMED registration and keeping it up to date after the deadline.
Read more about the latest EUDAMED status updates, or contact our team today to make sure your devices are registered on time.
Sources
- Eur.Lex (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. EUR-Lex. Retrieved on 20 October 2026.
- Eur.Lex (2025). Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices. EUR-Lex. Retrieved on 20 October 2026
- European Commission (2026). Medical Devices – EUDAMED: Overview. Retrieved on 20 October 2026.
- European Commission (2024). Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860. Retrieved on 20 October 2026.
- European Commission (2025). Transition period – Legacy and Regulation devices placed on the market before the mandatory use. Retrieved on 20 October 2026.
- European Commission (2026). EUDAMED Information Centre – Legacy devices: EUDAMED DI identification information. Retrieved on 20 October 2026.
- European Commission (2026). EUDAMED Information Centre – Machine-to-machine data exchange user guide. Retrieved on 20 October 2026