EUDAMED Registration

EUDAMED Registration

EUDAMED database

The European Database on Medical Devices (EUDAMED) is a cornerstone of the regulatory framework introduced under EU MDR 2017/745 and IVDR 2017/746. Its purpose is to create a centralized, transparent system that tracks medical devices throughout their entire lifecycle in the European Union.

EUDAMED is not just a database, it is a comprehensive platform that integrates multiple electronic modules to collect, manage, and share information about medical devices, manufacturers, authorized representatives, importers, and notified bodies. By consolidating this data, EUDAMED strengthens regulatory oversight, improves coordination among EU Member States, and enhances public trust in medical technologies.


Key Objectives

  • Transparency: Provide clear and accessible information for healthcare professionals, patients, and the public.
  • Regulatory Efficiency: Streamline communication between manufacturers, notified bodies, and national authorities.
  • Lifecycle Tracking: Offer a dynamic view of devices from initial registration through post‑market surveillance.
  • Safety and Vigilance: Support early detection of risks and ensure rapid response to adverse events.


Structure of EUDAMED

The system is composed of six interconnected modules:

1. Actor registration

2. Unique Device Identification (UDI) and device registration

3. Notified bodies and certificates

4. Clinical investigations and performance studies

5. Vigilance

6. Market surveillance


Broader Impact

EUDAMED represents a major step toward harmonized regulation in Europe. It ensures that medical devices entering the EU market meet consistent standards of safety and performance, while also making regulatory information more accessible than ever before. For manufacturers, it means greater accountability and the need for accurate, timely submissions. For regulators, it provides a powerful tool to monitor compliance and coordinate across borders.