What is the EUDAMED database?

What is stored in the EUDAMED?

EUDAMED is part of the European legislation for medical devices, in particular the Medical Devices Regulation (MDR) and the In-vitro Diagnostic Medical Devices Regulation (IVDR), which are in force in the EU. The EUDAMED database will comprise a total of 6 interconnected modules.

1. Module ACT – Registration
This module allows manufacturers, importers or representatives of medical devices to register and be clearly identified later.

2. UDI Module – Identification
The UDI module will contain all specific information per medical device and will have the same functions as the comparable database of the American Health Authority (FDA) GUDID .

3. Module CRF – Certificate
Every medical device distributed in Europe will in future have a valid approval certificate confirming that the product meets all legal requirements. These certificates will in future be managed in the CRF module.

4. Module CIPS – Clinical Investigation
According to the new Medical Devices Regulation (MDR), manufacturers of medical devices are required to perform a clinical assessment for all their medical devices, regardless of risk class, including post-market clinical follow-up (PMCF). The results of these studies will be publicly available through this module.

5. Module VGL – Vigilance
Every serious incident involving medical devices must be documented in the VGL module of the EUDAMED database. The technical documentation must specify the number and type of incidents. Security corrective actions must also be reported.

6. Module MSU – Market surveillance
Finally, the MSU module provides feedback on the results of market surveillance. The competent authorities are the ones who carry out market surveillance and publish the reports.