EUDAMED And The 2017 EU In-Vitro Diagnostic Regulation (IVDR)

Introduction

In January 2024 the European Commission decided to delay some elements of IVDR.  But, to protect patient care and safety they at the same time agreed to speed up the launch of some parts of the European Database on Medical Devices (EUDAMED).

What Is EUDAMED

EUDAMED is the IT system established by IVDR, and is integral part of the implementation of the regulation.  While the use of EUDAMED is currently voluntary, some modules are already available:

1) The module on Actor registration is available since December 2020

2) The module on UDI/device registration is available since October 2021

3) The module on Notified Bodies and Certificates is available since October 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities

4) The remaining module (Vigilance, Clinical Investigation & Performance Studies and Market Surveillance) are under development and will be released when EUDAMED is declared fully functional

EUDAMED And Patient Safety

Given that EUDAMED is the comprehensive database of critical information on medical devices in the EU, making sure all necessary languages are available within the database on an accelerated basis is an important way both EU regulatory authorities and manufacturers can contribute towards patient safety.

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