The European database on medical devices (EUDAMED) is a database set up and maintained by the European Commission. Eudamed aims to improve openness and transparency regarding medical devices available on the EU market by, among other things, increasing access to information on medical devices for healthcare professionals and citizens, and by enhancing coordination within the EU between different Member States.
A centralised database makes device basic information, such as device identification, certificate, manufacturer, authorised representative and importer, available to all stakeholders. Additionally, the Eudamed database provides the public and healthcare professionals with sufficient information on the following:
- reports on clinical trials on medical devices and studies on the performance of in vitro diagnostic devices, summaries of the main safety and performance aspects of the device, and results of the clinical evaluation of the device
- field safety notices submitted by the manufacturers and certain aspects of serious incident reports.
The database is structured around 6 interconnected modules and a public website:
- Actor registration (manufacturers, authorised representatives and importers)
- UDI/devices registration
- Notified bodies and certificates
- Clinical investigations and performance studies
- Vigilance and post-market surveillance
- Market surveillance
The deployment of Eudamed will be carried out in stages. The actor module was deployed in December 2020, and the devices module will be deployed next.
EUDAMED (European commission)
Unique Device Identifier - UDI (European commission)
Unique Device Identification (UDI) System (European commission)