Can German hospitals see Eudamed entries?

Yes. A large part of the data is public: registered economic operators, devices and certificates. Hospital buyers use it to check a supplier's claims before a listing.

The Single Registration Number identifies an economic operator in Eudamed — one per role. It is issued after actor registration and is required, among other things, when applying to a notified body.

Does the importer have to register as well?

Yes. Importers register as economic operators in their own right. Before placing a device on the market they also verify that it is registered in Eudamed and add their own details to the entry.

Regulatory

Eudamed

European Database on Medical Devices

The central EU database for medical devices. Registration is mandatory under the MDR — visible to authorities, hospitals and the public.

Last reviewed: 14 October 2026

Eudamed is the database operated by the European Commission for medical devices under the MDR (EU) 2017/745. Manufacturers, authorised representatives and importers register there as economic operators, and their devices are registered with the associated UDI data. Use of the first four modules has been mandatory since 28 May 2026.

In practice in the German hospital market

Hospital buyers increasingly check Eudamed entries themselves before listing a product — an unregistered device drops out of the shortlist immediately.

The six modules at a glance

Eudamed consists of six interlinked modules. They were developed separately and become mandatory one by one:

Actor registration — manufacturers, authorised representatives, importers and system or procedure pack producers receive a Single Registration Number (SRN).
UDI and device registration — the Basic UDI-DI and UDI-DI of every device with its master data.
Notified bodies and certificates — the certificates issued by notified bodies.
Clinical investigations and performance studies
Vigilance and post-market surveillance — incident reports, field safety corrective actions, trend reports.
Market surveillance — the exchange between national authorities.

Since when has Eudamed been mandatory?

Originally, Eudamed was only to become mandatory once all six modules were functional. Regulation (EU) 2024/1860 changed that: a module becomes mandatory once the Commission announces its functionality in the Official Journal.

For actor registration, UDI and device registration, notified bodies and market surveillance, this happened with Commission Decision (EU) 2025/2371 of 26 November 2025. After a six-month transition, use has been mandatory since 28 May 2026. The modules for clinical investigations and vigilance will follow later.

Devices already on the market before that date benefit from staggered transition periods. Which deadline applies to your portfolio depends on the certification status of each device — this should be checked device by device.

What non-EU manufacturers need to know

For a manufacturer based outside the EU, Eudamed is not the first step but the third. The sequence:

Appoint an EU authorised representative and set out the mandate in writing (MDR Article 11). The manufacturer’s registration is linked to this mandate.
Secure the PRRC — at the manufacturer and at the authorised representative (MDR Article 15).
Actor registration in Eudamed. The SRN is issued by the competent authority of the member state in which the authorised representative is established.
Assign the UDI and register the device data before placing the device on the market. Certificates are entered by the notified body itself.
Maintain the data — changes to the device, the labelling or the actor data have to be reflected promptly.

In practice, the most common bottleneck is not the database but data quality: incomplete UDI master data, or discrepancies between Eudamed, the label and the technical documentation, surface at the latest when the hospital purchasing department checks them.

How MEX supports you

In our MDR Compliance & Regulatory Affairs module, Eudamed registration is part of the market entry: the authorised representative role and PRRC through your German entity, actor and device registration, and maintenance of the UDI master data. You meet the obligation without building a regulatory affairs department of your own in Europe.

Frequently asked questions

Can German hospitals see Eudamed entries?: Yes. A large part of the data is public: registered economic operators, devices and certificates. Hospital buyers use it to check a supplier's claims before a listing.
What is an SRN?: The Single Registration Number identifies an economic operator in Eudamed — one per role. It is issued after actor registration and is required, among other things, when applying to a notified body.
Does the importer have to register as well?: Yes. Importers register as economic operators in their own right. Before placing a device on the market they also verify that it is registered in Eudamed and add their own details to the entry.

Source: ec.europa.eu/tools/eudamed

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