EUDAMED Technical
Specification & Documentation
EUDAMED Technical Specification & Documentation
Type
Release Date
Archive
The new release updates some functionalities for the users of the UDI/Device and Certificates modules of EUDAMED. The following are known issues that
have been reported that will be prioritized and addressed in the coming period.
8 Sep, 2025
This document outlines a brief overview of the main new features in EUDAMED v2.0 compared to the previous production release.
2 Sep, 2025
v1.2.1
September 2021 MTE Feedback Playground With Responses From EUDAMED Team
9 Sep, 2025
Internal Section - Delete Before Publication
28 May, 2025
This "Business Rules" document contains the constraints, limitations and business rules that drive the implementation of EUDAMED.
9 Sep, 2025
This "Enumerations" document contains the value lists for drop down elements and lists where a limited set of values can be selected.
9 Sep, 2025
Featured White Paper
EUDAMED FAQ For Compliance
Today, Medical Device manufacturers are staring down the barrel of a number of critical compliance deadlines specific to EUDAMED (European Database for Medical Devices) and you need to know the processes and systems that can simplify this journey. This eBook is intended to serve as a reference tool and mini-guide book as your team navigates the complexities of Medical Device Regulations (EU-MDR).