EUDAMED is the EU's central database for medical devices, and registering in it is now mandatory. Since May 28, 2026, every new medical device and IVD must be registered before it's placed on the EU market. Devices that were already on the market before that date, including legacy devices, have a deadline of November 27, 2026.
This guide covers who needs to register, what the deadline applies to, what information is required, and how to make sure your labels and your EUDAMED records say the same thing.
Key Dates
EUDAMED has been rolled out module by module under Regulation (EU) 2024/1860. On November 26, 2025, the Commission adopted Decision (EU) 2025/2371 declaring four modules functional: Actor registration, UDI/Device registration, Notified Bodies and Certificates, and Market Surveillance. The notice was published in the Official Journal on November 27, 2025, which started the clock:
- Six months later (May 28, 2026), use of the four modules became mandatory.
- Twelve months later (November 27, 2026), devices already on the market must be registered.
- Eighteen months later (May 27, 2027), notified bodies must have entered certificate information.
Who Must Register What, and by When
Economic operators (manufacturers, authorized representatives, importers, and system or procedure pack producers) must be registered in the Actor module and hold a Single Registration Number (SRN). This has been mandatory since May 28, 2026, and it's a precondition for registering devices.
New devices (first unit placed on the EU market on or after May 28, 2026) must be registered in the UDI/Device module before the first unit is placed on the market.
Existing devices (first unit placed on the market before May 28, 2026, with more units to follow after that date) must be registered by November 27, 2026. This covers both:
- MDR and IVDR devices that were already on the market but not yet registered, and
- Legacy devices, meaning devices still placed on the market under a certificate or declaration issued under the old Directives during the transition period.
Devices that don't need registering include custom-made devices (with some exceptions for Class III implantables) and devices no longer being placed on the market, unless a vigilance report requires registration.
Selling in Switzerland too? EUDAMED registration doesn't cover it. Switzerland has its own database, swissdamed, with separate registration obligations that became mandatory on July 1, 2026.
Legacy Devices: What's Different
Legacy devices don't have a Basic UDI-DI in the MDR sense. They're typically registered with a EUDAMED-DI and a EUDAMED-ID, which EUDAMED can generate, although an existing UDI-DI can be used in some cases. They also don't need the full MDR or IVDR device data set.
If a legacy device has since been certified under the MDR or IVDR and that version is already registered, the legacy version generally doesn't also need to be registered, unless vigilance applies. The Commission's user guide on legacy devices covers the details, and it's worth checking each case against it.
For many manufacturers, legacy devices make up most of the portfolio, so this is where the bulk of the registration work sits.
What You Need Before You Register
- An SRN for the manufacturer and, where relevant, the authorized representative
- Complete UDI and device data for each device: identifiers, device name and model, risk class, nomenclature code (EMDN), and the other required data elements
- Certificate information where a notified body is involved. For some higher-risk devices, the registration is routed to the notified body for confirmation before it's published.
- A plan for bulk registration if you have many devices. Bulk uploads use XML files that must follow EUDAMED's schemas exactly, and a single formatting error can reject the whole upload, so allow time for testing.
The Commission's EUDAMED page links to the data dictionaries and user guides for each module.
Where Registration Meets Labeling
EUDAMED registration isn't only a data entry task. The data you register has to match what's printed on your devices and packaging:
- The UDI-DI on the label at each packaging level must match the registered UDI-DI for that level.
- The device name, model, and reference on the label must match the registered data.
- The EU authorized representative named on the label must match the one linked to the device in EUDAMED.
- Changes need to reach both. A label change that affects registered data, such as a new packaging configuration, means an update in EUDAMED too, and vice versa.
Because much of this data is publicly visible, a mismatch between label and database can be seen by regulators, customers, and anyone checking. Our UDI Labeling Requirements guide covers UDI consistency across packaging levels in detail.
A Practical Plan Before November 27
- Confirm your SRNs for every relevant economic operator.
- List every device still being placed on the market, including legacy devices, and flag which are already registered.
- Decide what doesn't need registering: discontinued devices, custom-made devices, and legacy versions already replaced by registered MDR or IVDR versions.
- Collect and check the data for each device before entering it, especially identifiers and nomenclature codes.
- Check labels against the data at every packaging level, so what you register matches what's printed.
- Test bulk uploads early, and leave time to fix rejected files.
- Coordinate with your notified body and authorized representative, where their confirmation or data is needed.
- Set up a process for keeping records current after registration, as labels and devices change.
After November 27
The deadline marks the end of the transition, not the end of the work. From then on:
- New devices must be registered before they're placed on the market.
- Registered data must be kept up to date as devices and labels change.
- Notified bodies have until May 27, 2027 to enter certificate information.
The proposed revision of the MDR and IVDR also touches UDI and EUDAMED, including making more UDI data public. We'll cover that as it progresses.
For the full picture of device labeling requirements, see our Medical Device Labeling Requirements guide, and for a pre-release check, the Medical Device Labeling Audit Readiness Checklist.
Frequently Asked Questions
What is the EUDAMED deadline for legacy devices?
November 27, 2026. Devices already on the EU market before May 28, 2026, including legacy devices, must be registered in EUDAMED by then if they'll continue to be placed on the market.
Is EUDAMED registration mandatory?
Yes. Use of the Actor, UDI/Device, Notified Bodies and Certificates, and Market Surveillance modules has been mandatory since May 28, 2026.
Do legacy devices need a Basic UDI-DI?
No. Legacy devices are typically registered with a EUDAMED-DI and EUDAMED-ID instead, which EUDAMED can generate.
Do discontinued devices need to be registered?
Generally no, unless a vigilance report requires it.
Content Compare verifies UDI carriers, device names, models, and other label data against your approved specification at every packaging level, so what's printed matches what you register. See how it works on your own labeling.