EUDAMED is the European database on medical devices. It brings together records about organisations, devices and regulatory activity, but its six modules are at different stages of rollout. Four became mandatory on 28 May 2026; the clinical-investigation and vigilance modules are not yet operational. European Commission overview
For a procurement team or someone checking a supplier, the useful first distinction is between an organisation’s registration, a device identifier and a certificate. Each record answers a different question.
Which EUDAMED modules are in use?
The table follows the Commission’s six-module structure. “Mandatory” describes the module’s rollout status; it is not a device-specific registration deadline or a statement that every field is publicly visible.
| Module | Purpose and rollout position |
|---|---|
| Actor registration | Records economic operators; mandatory from 28 May 2026. |
| UDI/device registration | Holds device identification information; mandatory from 28 May 2026. |
| Notified bodies and certificates | Records certificates and related decisions; mandatory from 28 May 2026. |
| Market surveillance | Supports competent authorities and the Commission; mandatory from 28 May 2026. |
| Clinical investigations and performance studies | Intended for study-related information; not yet operational. |
| Vigilance and post-market surveillance | Intended for incident and surveillance information; not yet operational. |
Sources: Commission rollout overview, Belgian regulator’s module descriptions.
Belgium’s regulator explains that most information in the first three modules is public, while access to the other three is more limited. A module being mandatory therefore does not make it an unrestricted public database. FAMHP guidance
An actor number identifies an organisation
The actor-registration module covers economic operators such as manufacturers, authorised representatives and importers. An Actor ID or Single Registration Number (SRN) is generated after the relevant competent authority assesses and approves the registration. Actor registration
That identifier concerns the registered organisation and its role. It should not be read as a certificate for every product the organisation supplies. When checking a supplier’s explanation, keep its actor registration separate from the records for the device concerned.
A UDI identifies a device record
UDI means Unique Device Identification. The Commission describes the UDI system as supporting device identification and traceability; manufacturers submit the associated device information to EUDAMED. UDI/device registration
An organisation number and a device identifier are therefore not interchangeable. A useful record check starts by establishing which kind of identifier you have, rather than treating any EUDAMED number as the same evidence.
Certificate records can change status
The notified-body module includes information about certificates issued and their amendments or supplements. It also records decisions such as suspension, reinstatement, withdrawal, refusal and restrictions. The Commission says this information is accessible to the public. Certificates module
This makes the status of the relevant certificate important, not just the existence of an entry. An old reference to a certificate cannot establish that its position remains unchanged.
There are also transition arrangements. For devices placed on the market under the EU Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR) before 28 May 2026, Belgium’s regulator says notified bodies have a further twelve months to register the latest certificate version and associated decisions. That is one reason not to assume the database became a complete historical catalogue overnight. Certificate transition guidance
Where to start a public-record check
The Commission’s EUDAMED overview links to the public site and separates it from restricted access. Use the module that matches the question: organisation, device or certificate. Where information is missing or unclear, establish the applicable transition and the relevant record with the responsible organisation before drawing a conclusion.
These records organise different kinds of regulatory information. A registration entry alone is not a clinical safety assessment, and this guide does not determine a particular device’s compliance.
Our Great Britain device-surveillance explainer covers a separate jurisdiction and reporting system.