European Database on Medical Devices (EUDAMED)

What is the European Database on Medical Devices (EUDAMED)?

EUDAMED is an IT system developed by the European Commission to uphold Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on diagnostic medical devices.

EUDAMED aims to provide a living picture of the medical device lifecycle and make it available to the European Union (EU). It aims to increase transparency by collating and processing information about medical devices and their manufacturers.

The six modules of EUDAMED include:

  1. Actor registration
  2. Unique device identification (UDI) and device registration
  3. Clinical investigations and performance studies
  4. Notified bodies and certificates
  5. Market surveillance
  6. Vigilance

How will EUDAMED improve healthcare?

By increasing transparency on medical devices, EUDAMED allows the public and healthcare professionals easier access to information on medical devices. This information includes safety and clinical performance summaries, clinical investigations, and vigilance reporting.

Making more information available will allow the public and healthcare professionals to make more informed decisions regarding medical devices. Furthermore, healthcare professionals can better match patients with devices, improving health outcomes.