What is EUDAMED?

EUDAMED, short for European Database on Medical Devices, is a centralized IT system developed by the European Commission. Its purpose is to enhance transparency, traceability, and regulatory oversight of medical devices within the European Union.

EUDAMED is a key component of the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746).

Objectives of EUDAMED

EUDAMED was designed to:

• Improve market surveillance by European authorities.

• Centralize information on medical devices, manufacturers, and certificates.

• Ensure transparency for patients, healthcare professionals, and the public.

• Facilitate regulatory compliance for manufacturers and notified bodies.
  

Main Modules of EUDAMED

EUDAMED is structured into six interconnected modules:

1. Actor Registration: Contains information about economic operators (manufacturers, authorized representatives, importers).

2. Device and UDI Registration: Enables the registration of medical devices and their Unique Device Identifiers (UDIs).

3. Notified Bodies and Certificates: Includes data on notified bodies and the certificates they issue.

4. Clinical Investigations and Performance Studies: Manages data related to clinical trials (for medical devices) and performance studies (for IVDs).

5. Vigilance: Collects and evaluates serious incidents, safety corrective actions, and trends.

6. Market Surveillance: Promotes cooperation and information-sharing among Member State authorities.
   

Who Uses EUDAMED?

• Manufacturers – to register their devices and meet regulatory requirements.

• Authorized representatives and importers – to ensure the compliance of products placed on the European market.

• Notified bodies – to register certificates and conformity assessments.

• Competent authorities – to monitor the safety and performance of devices.

• Healthcare professionals and the public – to access safety information and device status.

Current Status (as of 2025)

As of 2025, EUDAMED is being rolled out progressively, with several modules already available for voluntary use. Mandatory use of the full system will only be enforced once the European Commission officially declares it fully operational. Until then, national systems and transitional measures remain in effect.

Why Is It Important?

EUDAMED is a critical part of the EU's strategy to ensure that medical devices are safe, reliable, and of high quality. By centralizing data and increasing transparency, EUDAMED strengthens public health protection and builds trust in medical technologies across Europe.