Glossary Updates12 new terms added to the glossaries · October 2, 2026, 22:44 CEST
AI TechDocKnowledge

Glossary · EU medical devices: MDR

EUDAMED

Also known as: European database on medical devices, EUDAMED database

EUDAMED is the European database on medical devices set up under Article 33 of the EU Medical Device Regulation (EU) 2017/745, which also serves the IVD Regulation (EU) 2017/746. It consists of modules for actor registration, UDI and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance.

  • EU
  • MDR
  • IVDR

In one sentence

EUDAMED is the EU database for medical devices and IVDs: actors, UDI and devices, certificates, clinical studies, vigilance and market surveillance.

Example

An importer registers in the actor module and receives its single registration number, then the manufacturer registers the Basic UDI-DI and UDI-DI data of a new blood pressure monitor and uploads its SSCP link.

How it applies

  • Modules: Actor registration, UDI and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance.
  • Gradual roll-out: Regulation (EU) 2024/1860 allows individual modules to become mandatory one by one, six months after the Commission publishes a notice on their functionality in the Official Journal. Check which modules are mandatory at the time of use.
  • Actors: Manufacturers, authorized representatives and importers register and receive a single registration number (SRN), used in certificates, declarations and vigilance reports; see economic operators.
  • Devices: Device data are keyed by the Basic UDI-DI and UDI-DI; see UDI.
  • Public access: Much of the data, such as registered devices, certificates and the SSCP, are publicly accessible; some data, such as vigilance details, are restricted to authorities.
  • Technical documentation: EUDAMED entries must match the label, the declaration of conformity and the technical documentation. Treat the registered data as controlled records and update them under change control when device data change.

EUDAMED vs. GUDID

EUDAMED is broader than a UDI database: besides device data it covers actors, certificates, clinical studies, vigilance and market surveillance. The FDA’s GUDID holds device identifier data only; US registration, adverse event reporting and premarket submissions run through separate FDA systems.