Regulatory update. From 28 May 2026, the use of several modules of the European database EUDAMED will become mandatory for economic operators in the medical device sector. This development marks a new step in the implementation of the European MDR regulation and in the structuring of the European system for medical device traceability.
Until now, the use of certain modules within the European database remained voluntary or only partially implemented. This situation is now changing: once modules are declared fully functional, their use becomes legally mandatory.
In other words, manufacturers will now have to integrate EUDAMED modules into their regulatory processes to maintain access to the European market.
EUDAMED modules: which modules are affected by the obligation?
EUDAMED is a European database designed to improve transparency and traceability of medical devices within the European Union.
It is structured around several functional modules, each dedicated to a specific category of regulatory information.
The main EUDAMED modules are:
- Actor registration module: registration of economic operators (manufacturers, authorized representatives, importers)
- UDI/device registration module: registration of medical devices and unique device identifiers (UDI)
- Notified bodies and certificates module: certificates issued by notified bodies
- Clinical investigations module: clinical investigations
- Vigilance module: reporting of incidents and corrective safety actions
- Market surveillance module: market surveillance
The European Commission specifies that this obligation aims to strengthen transparency and coordination between national authorities.
https://health.ec.europa.eu/medical-devices-sector/new-regulations/eudamed_en
The first EUDAMED modules become mandatory
A key milestone will occur on 28 May 2026: the use of the first four EUDAMED modules will become mandatory for economic operators.
This obligation results from Regulation (EU) 2024/1860, which provides for the progressive deployment of the modules of the European database.
The modules concerned in this first phase are:
- the Actor module (economic operators)
- the UDI/device module
- the Notified bodies and certificates module (NBs & Certificates)
- the Market surveillance module
These modules represent the core building blocks of the European information system for medical devices.
What this means in practice for economic operators
With the entry into force of this obligation, manufacturers, authorized representatives and importers will notably have to:
- register in EUDAMED to obtain their Single Registration Number (SRN)
- assign a Unique Device Identifier (UDI/IUD) to their devices
- register their devices in the European database using the EMDN nomenclature
- ensure the consistency of information throughout the device lifecycle
These requirements aim to strengthen medical device traceability and improve coordination between competent authorities, notified bodies and economic operators.
A database designed to improve medical device traceability
EUDAMED has been designed to enhance transparency and traceability of medical devices within the European Union.
In particular, the database aims to provide:
- unique identification of devices
- improved visibility of issued certificates
- strengthened coordination between national authorities
- access to certain information for the public
In this context, the mandatory use of the first EUDAMED modules represents a major step towards the full implementation of the system.
Operational challenges for manufacturers
While the mandatory use of the first EUDAMED modules represents progress in terms of transparency, it also requires organizational adjustments for manufacturers.
The operational implementation of EUDAMED relies on the structuring and continuous management of regulatory data related to medical devices.
Several practical challenges are commonly identified by industry stakeholders:
- structuring and managing unique device identifiers (UDI/IUD)
- ensuring the quality and consistency of data recorded in the European database
- aligning internal systems with EUDAMED requirements
- coordinating between regulatory affairs, quality and vigilance teams
In this context, the mandatory use of EUDAMED modules is leading companies to strengthen governance and long-term management of their regulatory data throughout the product lifecycle.
Conclusion
The mandatory use of EUDAMED modules marks a significant evolution in the European regulatory framework for medical devices.
Beyond compliance, this change requires companies to implement structured and sustainable data management processes. EUDAMED is no longer a simple regulatory tool, but a central component of medical device lifecycle management in Europe.
At BluePharm, we support healthcare stakeholders in understanding these new requirements and implementing solutions adapted to their regulatory and organizational needs.
