EUDAMED (European Database on Medical Devices)

EUDAMED is a centralized, multipurpose database established under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) to improve transparency, traceability, and regulatory oversight of medical devices and in vitro diagnostics marketed in the European Union.

EUDAMED is designed to collect and maintain structured data across the full device lifecycle. It serves manufacturers, authorized representatives, importers, notified bodies, competent authorities, and the public by providing access to critical regulatory information such as device registrations, clinical investigations, post-market surveillance, and vigilance data. EUDAMED registration is not linked to CE Marking issuance but is required prior to placing products on the EU market.

EUDAMED is made up of six interconnected modules:

1. Actor Registration

2. UDI/Device Registration

3. Notified Bodies and Certificates

4. Market Surveillance

5. Post-Market Surveillance and Vigilance (pending implementation)

6. Clinical Investigations and Performance Studies (pending implementation)

As of November 2025, the European Commission declared the first four modules fully functional via Implementing Decision (EU) 2025/2371. Mandatory use of the Actor, UDI, Notified Bodies and Certificates, and Market Surveillance modules begins on 28 May 2026.

EUDAMED Registration Requirements

All economic operators (excluding distributors) must complete Actor Registration to obtain a Single Registration Number (SRN). Device registration via the UDI module must follow and includes detailed data on device characteristics, classification, and market presence. Manufacturers must also coordinate with their notified bodies to link Basic UDI-DIs with conformity assessment certificates.

For up-to-date guidance, stakeholders should consult the European Commission’s official EUDAMED documentation and the latest notices published in the Official Journal of the EU.

Is EUDAMED mandatory for all medical device and IVD manufacturers?

Yes, EUDAMED registration will become mandatory for all manufacturers marketing devices in the EU regardless of classification or legacy status. As of 28 May 2026, use of the four validated modules (Actors, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance) will be required. Manufacturers must register both their organizations and their devices by these deadlines.

What is a Single Registration Number (SRN)?

The SRN is a unique identifier assigned to each registered economic operator in EUDAMED. It is essential for tracking regulatory responsibilities and must be included on key documentation such as Declarations of Conformity, CE applications, and Field Safety Notices.

Is device registration in EUDAMED the same as obtaining CE Marking?

No. CE Marking is granted through conformity assessment under the MDR or IVDR. EUDAMED registration is a separate post-certification requirement and must be completed before a device can be marketed in the EU.

What are the available methods for submitting data to EUDAMED?

Data can be submitted through:

• Manual entry via the user interface

• XML upload via the portal (semi-automated)

• Machine-to-Machine (M2M) automated data exchange

The appropriate method depends on the manufacturer’s portfolio size and IT capabilities.

Will EUDAMED data be publicly accessible?

Certain data fields, such as device registration status, SRNs, and safety summaries (SSCPs/SSPs), will be publicly accessible. However, sensitive commercial or clinical data will remain restricted to competent authorities and relevant regulatory bodies.

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