Understanding EUDAMED: A central element of the European Medical Device Regulation (MDR)

The European Medical Devices Database, better known as EUDAMED, plays a fundamental role in the regulation of medical devices within the European Union. Established by the European Commission, EUDAMED aims to centralize information related to the traceability, safety, and compliance of medical devices placed on the European market.

Its main objective is to increase transparency and improve post-market surveillance, while facilitating the exchange of information between manufacturers, competent authorities, notified bodies and the general public.

What is EUDAMED used for in practice?

EUDAMED was designed to support the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It brings together several interconnected modules that cover different aspects of regulatory compliance:

• Recording the actors: manufacturers, agents, importers, and producers of systems must register in the database.

• Unique Device Identification (UDI): each product must be identified in a standardized manner to ensure its traceability.

• Certificates and notified bodies: certification data is centralized.

• Clinical investigations and performance studies.

• Incident monitoring and vigilance.

• Periodic safety and performance reports (PSUR, SSCP, etc.).

Why is EUDAMED so important for manufacturers?

Joining EUDAMED is becoming a must for any manufacturer wishing to market medical devices in the European Union. Here's why:

• Regulatory compliance: EUDAMED is a pillar of the MDR. Failure to comply with it risks being denied access to the European market.

• Improved traceability: thanks to the UDI and the centralization of data, products can be known before and during their placing on the European market.

• Transparency: part of the information is accessible to the public, which strengthens the confidence of health professionals and patients.

• Increased responsiveness: in the event of an incident or product recall, the authorities have rapid access to the necessary data.

A calendar that is accelerating

Din January2026, medical device manufacturersmust imperatively:

• Have an active SRN (Single Registration Number),

• Declare their devices in EUDAMED,

• Provide a valid UDI identifier for each device.

• And ensure the continuous updating of data related to their products.

Time is of the essence: Companies that wait until the last minute risk facing integration delays, compliance errors, or even a business blockage.

Where is the deployment of EUDAMED?

The full deployment of EUDAMED is taking place in stages. Some modules are already operational, such as:

• The Actor Recording Module

• The UDI / Devices module

• The module on notified bodies and certificates

The other modules (vigilance, clinical studies, market surveillance) are in the final stages of development or testing. Once all modules are activated, EUDAMED will become fully mandatory for all stakeholders.

What manufacturers need to do now

Here are some essential steps:

1. Obtain an SRN (Single Registration Number)via the actor recording module.

2. Assign a UDI-DI and a UDI-PIto each device according to GS1, HIBCC or ICCBBA standards.

3. Prepare technical datanecessary for their integrationdans EUDAMED.

In summary

EUDAMED is not just an administrative formality. It is an essential infrastructure that guarantees the quality, safety, and traceability of medical devices on the European market. For manufacturers, compliance is not only an obligation, but also an opportunity to strengthen their credibility and competitiveness in an increasingly demanding environment.

Official and recent sources: link