A row of sleek, glass-fronted server racks in a bright, modern data center—ideal for eudamed compliance—with white floors and ceiling lights, reflecting a clean, high-tech environment.

What is EUDAMED?

The European Database on Medical Devices (EUDAMED) is a digital platform and database developed by the European Commission as part of implementing the MDR (Medical Device Regulation) and the IVDR (In Vitro Diagnostic Regulation).

It serves as a central information database covering the entire lifecycle of medical devices and IVDs placed on the EU market. Mandatory use of EUDAMED will begin following the official declaration that the modules are fully operational.

Which EUDAMED Modules Exist?

EUDAMED consists of a public website and six modules:

  • Actor Registration
  • Unique Device Identification (UDI) and Device Registration
  • Notified Bodies and Certificates
  • Clinical Investigations and Performance Studies
  • Vigilance and Post-Market Surveillance
  • Market Surveillance
EUDAMED diagram showing six components—Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, Clinical Investigations, Vigilance, and Market Surveillance—all linked to the European Commission.

The first four modules (Actor Registration, UDI/Device, Notified Bodies/Certificates, and Market Surveillance) are already available and mandatory to use. The remaining modules will be rolled out gradually. The European Commission provides the current rollout timeline for full EUDAMED functionality.

A graphic showing the EUDAMED logo—a blue circle with yellow stars and "European Commission" inside. Below, labeled boxes outline EUDAMED modules: Actor Registration, UDI and Device Registration, Notified Bodies, Clinical Investigations, Vigilance, and Market Surveillance.
View the EUDAMED rollout timeline

Not sure which EUDAMED modules are relevant for your products or studies? We are happy to support you with registration and onboarding. Get in touch!

Contact us now

Eugen Brenninger & Agnes Bulla-Lilge, Commercial Operations

You Might Also Be Interested In

A scientist in a green lab coat and gloves operates laboratory equipment in a modern CRO Wiki lab. In the background, two other scientists work at separate stations. The setting appears clean and organized.

CRO Wiki

From IVDR and performance studies to ISO 13485: our CRO Wiki covers the most important terms, processes, and regulatory fundamentals of IVDs and CDx – grounded in expertise and presented in plain language.
Merh erfahren
A scientist wearing blue gloves and safety glasses examines samples on a slide through a microscope in a laboratory, conducting ivdr performance studies with scientific equipment visible in the background.

Diagnostics

From study planning through execution to submission-ready reports: TRIGA-S supports you with specialised expertise, a modular service portfolio, and a dedicated point of contact.
Merh erfahren
A scientist wearing safety goggles, gloves, and a lab coat stands in a laboratory specializing in pharma services, holding a piece of lab equipment and smiling at the camera. Shelves and lab supplies are visible in the background.

Pharma

From exploratory R&D analytics to submission-ready CDx validation: We support pharmaceutical companies with modular, IVDR-specialised services and dedicated points of contact.
Merh erfahren

EU: European Union

EUDAMED: European Database on Medical Devices

IVDs: In vitro diagnostics

IVDR: In Vitro Diagnostic Regulation

MDR: Medical Device Regulation

UDI: Unique Device Identification

Logo of TRIGA-S featuring a stylized yellow and blue square with gray and white curved lines on the left, followed by the text TRIGA-S in bold blue capital letters on a light background.
Contact
Youtube Instagram Linkedin
Logo of TRIGA-S featuring a stylized yellow and blue square with gray and white curved lines on the left, followed by the text TRIGA-S in bold blue capital letters on a light background.
Contact
Youtube Instagram Linkedin