EUDAMED – CE Marking on the Path to Digitalisation
- Cinterqual
- Jun 29
- 2 min read
In today’s digital world, digitalisation is no longer a trend but a fundamental requirement. It is reshaping how we work, communicate, and make decisions—especially in highly regulated sectors such as healthcare.
In the context of CE Marking for medical devices, the EUDAMED (European Database on Medical Devices) plays a crucial role in the digital transformation. This platform aims to centralise information across the EU, enhancing transparency, safety, regulatory efficiency, and facilitating data access for authorities, professionals, and the public.
What is EUDAMED?
EUDAMED is a database developed by the European Commission as part of the implementation of:
Regulation (EU) 2017/745 – Medical Devices (MDR)
Regulation (EU) 2017/746 – In Vitro Diagnostic Devices (IVDR)
Supported by Regulation (EU) 2021/2078, which outlines the operational framework for EUDAMED.
The Six Core Modules of EUDAMED
EUDAMED is built on six main modules:
Registration of economic operators (Manufacturers, authorised representatives, importers, and system/procedure pack producers)
Device registration / UDI database
Notified Bodies and Certificates
Post-market surveillance
Market surveillance
Clinical investigations and performance studies
Currently, the following modules are available:
Module 1 – Actors: Available since December 2020
Module 2 – UDI/Devices: Available since October 2021
Module 3 – Notified Bodies and Certificates: Available since October 2021 (excluding CECP functionalities)
The remaining modules are under development, with full deployment expected by 2027.
Who Has Access to EUDAMED?
Data entered in EUDAMED is accessible to:
The European Commission
Competent Authorities of EU Member States
Notified Bodies
Economic Operators
Sponsors
The public (based on defined legal access levels)
Where to Find More Information?
For official documentation, user guides and updates, visit the EUDAMED Information Centre:
Digital transformation is reshaping regulatory compliance. Tools like EUDAMED are not only enhancing compliance standards but also strengthening the recognition of the CE Mark across Europe.
Need help with CE Marking or an authorised representative?
Get in touch with us – we have the expertise and resources to support you.
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