EUDAMED
European Database on Medical Devices
The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746).
EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g. manufacturers). In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.
EUDAMED will be composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.
As an example this is a link to the Hunter Scientific devices list on EUDAMED. From here you can link our product codes directly.
https://ec.europa.eu/tools/eudamed/
This is the first time clinicians and end users have been able to check the validity of a Product Code against a manufacturer and check it is currently CE marked. If you follow the link it will take you to Hunter Scientific Pasteur pipettes showing they are Class IIa and current. In time the MDR CE certificate as above on this page will also be available. We will update these changes as they happen.
For the first time clinicians and end users are able view all the information on a Medical Device manufacturer from a single EU verified source.
EUDAMED to Become Mandatory as from 28th May 2026
This means the following modules will become mandatory from 28th May 2026:
- Actor registration
- UDI/Devices registration
- Notified Bodies & Certificates
- Market Surveillance
