EUDAMED Registration

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).

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.

We are not learning this at your expense. Medex is itself a medical device manufacturer with its own SRN (TR-MF-000057496) and its own devices registered in EUDAMED. The people who file our records will file yours.

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, TR-MF-000057496 as manufacturer and TR-IM-000056252 as importer, all three searchable in the EUDAMED public actor database without asking us for anything.