EUDAMED Registration for Non-EU Manufacturers

EUDAMED is the European database for medical devices. Before your devices can appear in it, both your company and your authorised representative must be registered as actors and hold a Single Registration Number (SRN).

What we register for you

We handle actor registration, verify or create your Basic UDI-DI and UDI-DI records, and register the authorised representative mandate that links your company to ours.

How the fee is counted

One device equals one Basic UDI-DI. Unlimited UDI-DI variants under the same Basic UDI-DI are covered by the base fee, and the first ten UDI-DI entries are included.

When registration has to happen

Article 31(1) of the MDR fixes the sequence: "Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI." Where a notified body is involved, that information has to be in the system before you apply to the notified body, not after. The same order applies to the device itself: under Article 29(3) the Basic UDI-DI is assigned before the manufacturer applies for conformity assessment, and the notified body then puts a reference to it on the certificate.

How the SRN is issued

You do not create an SRN yourself. Under Article 31(2), after verifying the data you submitted, "the competent authority shall obtain a single registration number ('SRN') from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer." The manufacturer then uses that SRN when applying to a notified body and when accessing EUDAMED to fulfil its Article 29 obligations.

The obligations that do not end at registration

This is where most actor records quietly lapse. Article 31(4) requires the economic operator to update the data "within one week of any change occurring in relation to the information referred to in paragraph 1". Article 31(5) requires confirmation of the accuracy of the data "not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter", and where that is not done within six months of those deadlines, "any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation". We track those dates for the devices under our mandate and act on them, because a lapsed actor record is a market access problem, not an administrative one.

Your record is public

Article 31(7) is explicit: the data entered under Article 31(1) "shall be accessible to the public". Anyone, including your competitors and your customers' procurement teams, can look your actor entry up. Ours can be checked the same way: TR-AR-000057550 as authorised representative, searchable in the EUDAMED public actor database without asking us for anything.

Mandatory EUDAMED dates

The Commission published the notice declaring the first four EUDAMED modules functional, Commission Decision (EU) 2025/2371, in the Official Journal of 27 November 2025. The four modules are actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. Under Article 123(3)(d) of the MDR, as amended by Regulation (EU) 2024/1860, the related obligations "shall apply from the date corresponding to 6 months from the date of publication of the notice referred to in Article 34(3)". The Commission gives that date as 28 May 2026.

Devices already on the market are covered by Article 123(3)(e): "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". The Commission's transition timeline gives 28 November 2026 as the deadline to register these devices in the UDI/device module, and 28 May 2027 as the deadline to register certificates issued under the MDR and IVDR before mandatory use of the notified bodies and certificates module.

For devices under our mandate we check that the Basic UDI-DI and UDI-DI records are complete before 28 November 2026. Source: European Commission, EUDAMED overview.

Registration of products in Türkiye (ÜTS) is handled through our Turkish-language site, medexmedikal.com