The authorised representative registers as an actor and the mandate is documented. The representative verifies that the declaration of conformity and technical documentation exist before it signs.
EUDAMED
EUDAMED registration: what changed in May 2026 and what falls due in November
For six years EUDAMED was voluntary and most US manufacturers left it alone. That ended on 28 May 2026. The database is now the place where a device is visible to European authorities, and the entry route for a company outside the Union runs through its authorised representative.
What became mandatory on 28 May 2026
Regulation (EU) 2024/1860 introduced a gradual roll-out of EUDAMED, module by module, instead of waiting for the full system. The Commission published its notice on the functionality of the first four modules on 27 November 2025, and the six-month transition in Article 123(3)(d) MDR ran from that date.
Since 28 May 2026 four modules are mandatory: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. The two remaining modules, vigilance and clinical investigations, are still in development and have no mandatory date.
The twelve-month obligation, in the words of the Regulation
Article 123(3)(e) MDR, as amended by Regulation (EU) 2024/1860:
no later than 12 months from the date of publication of the notice referred to in Article 34(3) in respect of the electronic system referred to in Article 33(2), points (a) and (b), manufacturers shall ensure that the information to be entered in Eudamed in accordance with Article 29 is entered in that electronic system, including regarding the following devices, provided that those devices are also placed on the market from 6 months from the date of publication of that notice
Counted from 27 November 2025, that puts the obligation at 27 November 2026. Read the second half of the sentence carefully. The obligation is written around devices that are also placed on the market from 28 May 2026 onwards, and it names two groups: devices for which the manufacturer has undertaken a conformity assessment under Article 52, and devices placed on the market under the transitional provisions in Article 120(3), (3a) or (3b). Much of the commentary circulating this summer flattens that into a blanket statement that every legacy device must be registered by 27 November. Before accepting either reading for a specific portfolio, the device history has to be checked against the wording.
The IVDR timetable is shorter, not longer
For in vitro diagnostics, Article 113(3)(fa) IVDR sets six months from the date in point (f) of that paragraph, not twelve. A company selling both a device and a companion diagnostic in Europe is therefore working to two different clocks, and the diagnostic side is the tighter one.
GUDID and EUDAMED are not the same data model
The most common mistake in a first EUDAMED submission is treating the GUDID record as a source to copy.
| Concept | United States | European Union |
|---|---|---|
| Top identifier | Device identifier for each version or model | Basic UDI-DI grouping devices with the same intended purpose, risk class and design |
| Registrant | Labeler | Manufacturer, with the actor record of a non-EU manufacturer created through its authorised representative |
| Issuing agencies | GS1, HIBCC, ICCBBA | GS1, HIBCC, ICCBBA, IFA |
| Certificate link | Not part of the listing | Notified body certificates linked to the registered devices |
| Company identifier | DUNS or FEI, obtained directly | Single registration number issued after a competent authority validates the actor record |
Why a US manufacturer cannot start this alone
The sequence matters more than the forms.
The manufacturer established outside the Union is registered through that representative, and a competent authority validates the record before a single registration number is issued.
Only then can device data be entered: Basic UDI-DI, each UDI-DI, risk class, intended purpose and the remaining attributes required by Annex VI.
Where the class requires a notified body, the certificates are linked to the registered devices. A device that is not registered cannot be linked.
What manufacturers ask about EUDAMED
Our device has been on the EU market since 2019 under an MDD certificate. Are we in scope?
Probably, through the transitional route in Article 120, but the answer depends on the certificate, the class and whether the device is still being placed on the market. This is checked device by device, not portfolio-wide.
Can our consultant enter the data for us?
Data entry can be delegated. Responsibility for the accuracy of the device data stays with the manufacturer, and the actor record of a non-EU manufacturer is tied to the mandated representative.
What happens if we miss the date?
The device data obligation is a legal obligation under the Regulation, enforced by national market surveillance authorities. The practical risk arrives earlier than any penalty: importers and distributors increasingly refuse to take goods that are not visible in EUDAMED.
Do we need a new SRN if we change representative?
The manufacturer keeps its registration, but the actor data has to be updated and the outgoing representative has its own duties on termination. Plan the handover before the mandate ends, not after.
Official basis checked on 15 August 2026
The MDR, the modular EUDAMED roll-out Regulation and the Commission EUDAMED overview were checked for the obligations described on this page.
Regulation (EU) 2017/745 (MDR) in EUR-Lex → · Regulation (EU) 2024/1860 in EUR-Lex → · European Commission: EUDAMED overview →
Plan the EU route
Map the work before committing to a certification timeline.
Use the US-to-EU hub to separate reusable evidence from European work, or review the wider service scope for manufacturers established outside the Union.