Overview of EUDAMED and the Lifecycle of Medical Devices in the EU

Overview

EUDAMED offers a dynamic insight into the entire lifecycle of medical devices that are available within the European Union. It links multiple electronic systems designed to gather and organize information on these devices, ensuring that data is consistent, secure, and accessible across all EU member states.

Purpose and Function

The European database on medical devices (EUDAMED) serves as a key tool for reinforcing transparency, improving market surveillance, and supporting regulatory frameworks under EU legislation. It helps authorities, manufacturers, notified bodies, and the public obtain reliable information about devices and related economic operators.

Structure and Subsystems

EUDAMED consists of several interlinked modules that manage various aspects of device regulation, including:

Each module operates independently but contributes to a single, integrated database that promotes coherence between stakeholders and facilitates public access to selected data.

Transparency and Public Access

Through EUDAMED, users can explore detailed information about authorized devices, their manufacturers, and regulatory documentation. The platform enhances patient safety by making essential product data publicly available and supporting traceability throughout the EU market.

"EUDAMED provides a living picture of the lifecycle of medical devices available in the European Union."

Governance and Implementation

Managed by the European Commission, EUDAMED plays a central role in applying the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Its gradual implementation phase ensures that each functional module is tested and integrated before full deployment.

Author’s Summary:
EUDAMED is the EU’s central database ensuring transparency, traceability, and regulatory oversight throughout the lifecycle of all medical devices on the European market.

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europa.eu europa.eu — 2025-11-27

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