What is EUDAMED?
EUDAMED is the European database on medical devices, set up under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). Manufacturers, authorised representatives and importers register themselves and their devices in it, and notified bodies record the certificates they issue. Four of its six modules have been mandatory since 28 May 2026, including actor registration and UDI/device registration.
Source: European Commission: EUDAMED overview
T. LozerCompliance Strategy Specialist · entroit GmbH
· Updated
The six EUDAMED modules
Part of EUDAMED is public: anyone can search registered companies, devices and certificates on its public site.
| Module | What it holds | Status (October 2026) |
|---|---|---|
| Actor registration | Manufacturers, authorised representatives and importers, each with a Single Registration Number (SRN) | Mandatory since 28 May 2026 |
| UDI/device registration | Device data, starting from the Basic UDI-DI | Mandatory since 28 May 2026 |
| Notified bodies and certificates | Certificates issued by notified bodies | Mandatory since 28 May 2026 |
| Market surveillance | Activities of national authorities | Mandatory since 28 May 2026, for authorities and the Commission |
| Vigilance and post-market surveillance | Incident reports and safety corrective actions | In development |
| Clinical investigations and performance studies | Studies on devices before and after approval | Under analysis |
Why mandatory use only started in 2026
The MDR originally made EUDAMED mandatory only once the whole system worked. Regulation (EU) 2024/1860 changed that to a module-by-module roll-out. The Commission confirmed that the first four modules work in Decision (EU) 2025/2371, published on 27 November 2025, and they became mandatory six months later. The two remaining modules become mandatory once the Commission confirms them too, without a voluntary phase beforehand.
EUDAMED registration and UDI
A manufacturer first registers as an actor and receives its SRN. It then registers each device under its Basic UDI-DI, the key that groups a device model, and the UDI-DI of each version and package. A device first placed on the market from 28 May 2026 must be registered beforehand. For devices that were already on the market before that date, the amended rules give manufacturers extra time.
Distributors do not register in EUDAMED. They do have to check, among other things, that a device carries the CE mark and, where applicable, that the manufacturer has assigned a UDI.
What EUDAMED means for your warehouse system
EUDAMED holds device master data, not your stock. When a notified body, an authority or a customer asks which units you received and supplied, the answer comes from your own records: UDI-DI, batch or serial number and expiry date on every goods receipt and every delivery, backed by an audit trail. Inventory management for medical devices should capture these identifiers by scanning, so you can trace each unit forwards and backwards. entroit stores them with every stock movement and includes an interface for EUDAMED and UDI data; meeting the MDR remains your responsibility.