What is EUDAMED?
The European Databank on Medical Devices (EUDAMED) is an IT system developed by the European Commission to increase transparency and improve surveillance of medical devices (and in vitro diagnostics) that are sold within the European Union. It serves a key functional role in the unique device identification (UDI) requirements included in the MDR and IVDR regulations.
This article excerpts from The Ultimate Guide to the EU/IVDR UDI ebook to highlight the specific role and associated requirements that the EUDAMED database plays in the new regulations.
Element 4: The UDI Database
The fourth component of the UDI system is entry of UDI and device information into the UDI database through EUDAMED. The MDR and IVDR require manufacturers to register all devices and submit specific information to the database before placing a device on the market. The core data elements provided through the UDI database will be accessible to the public free of charge. The list below outlines all of the required information for device registration.
Annex VI, Part A of 2017/745, states that the UDI database will contain all information about devices presently on the market and discontinued products. The database is designed to allow for linking across all packaging levels of the device. For all devices currently on the market, manufacturers are required to periodically verify the accuracy of the information in the database. If any changes are made to a device that do not require a new UDI-DI, manufacturers must still update the database within 30 days.
Information to be submitted with the device and economic operator registration must include
- Economic operator information (2017/745 Annex VI, Part A(1)):
- Information relating to the device
- Manufacturing information
The tables below outline all of the specific information that must be submitted to EUDAMED:
|Economic Operator Information|
|Information Relating to the Device|
In addition to this information, the European Commission recently released the UDI HelpDesk. The HelpDesk will provide support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system.
To learn more about EUDAMED and the European UDI system including a UDI overview, formats and issuing entities, implementation timelines, and key differences between the EU and US UDI systems, please register to download the full ebook.