EUDAMED is the European database on medical devices. It was provided for by Regulation (EU) 2017/745 on medical devices, known as the MDR, and by Regulation (EU) 2017/746 on in vitro diagnostic medical devices, known as the IVDR.
Its objective is simple to state, but structuring for manufacturers: to centralise, harmonise and make traceable the regulatory information relating to actors, devices, certificates, investigations, vigilance and market surveillance.
Before EUDAMED, some of this information circulated through national systems or exchanges between authorities. With EUDAMED, the European Union aims for a common database, more readable for competent authorities, notified bodies, economic operators and, for certain information, the public.
What is EUDAMED?
EUDAMED stands for European Database on Medical Devices. It is a European IT system set up and administered by the European Commission. The database covers medical devices falling under the MDR and in vitro diagnostic medical devices falling under the IVDR. It does not replace the substantive regulatory obligations: it serves to declare, organise, link and make accessible certain information required by the regulations.
For a manufacturer, EUDAMED is therefore not merely an administrative portal. It is a tool that links together several key elements of the regulatory file: the identity of the operator, the devices, the UDI identifiers, the certificates, certain vigilance information and interactions with the authorities.
Why is EUDAMED important for manufacturers?
EUDAMED addresses three main objectives:
- Traceability: devices are linked to their manufacturers, to their UDI identifiers, to their certificates and to the economic actors concerned.
- Transparency: certain information becomes accessible to the public, in particular on operators, devices or certificates, depending on the modules and the applicable publication rules.
- Regulatory coordination: competent authorities and notified bodies have a common system, which should facilitate market surveillance, vigilance and the monitoring of devices.
In practice, EUDAMED requires manufacturers to better structure their regulatory data. An incomplete, inconsistent or poorly prepared registration can generate delays, requests for correction or non-conformities during an audit or a regulatory review.
Where does the EUDAMED rollout stand in 2026?
The rollout of EUDAMED was for a long time gradual. This gradual approach was formalised by Regulation (EU) 2024/1860, which amended the MDR and the IVDR in order to allow implementation module by module.
An important milestone was reached with Decision (EU) 2025/2371 of the Commission, published in the Official Journal of the European Union on 27 November 2025. This decision confirmed the functionality of four electronic systems of EUDAMED.
Since 28 May 2026, the use of the following four modules is mandatory:
- registration of actors;
- UDI/device registration;
- notified bodies and certificates;
- market surveillance.
The modules relating to clinical investigations/performance studies and to vigilance/post-market surveillance still remain to be monitored according to their own timeline for availability and obligation. It is therefore important not to consider that EUDAMED is “fully mandatory” in a uniform manner for all of its modules.
The 6 EUDAMED modules
EUDAMED is structured around six modules.
1. Actors module
The Actors module is the entry point for economic operators. It concerns in particular manufacturers, authorised representatives, importers and producers of systems or procedure packs who submit their application to obtain a unique identifier called the SRN, for Single Registration Number. This unique number identifies the actor in EUDAMED, as well as on the European medical devices market, and makes it possible to link its data to the other modules.
A single organisation may have several roles. For example, a company may act as both manufacturer and importer. In this case, it may need to have a separate registration for each role, depending on the applicable situations.
2. UDI/Devices module
This module allows the registration of devices and their UDI data. It contains in particular information on the device, its classification, its identifiers, its manufacturer, its regulatory status and, where applicable, the information associated with the certificates.
For manufacturers, this is often the most demanding module in terms of data preparation. The information must be consistent with the technical documentation, the EU declaration of conformity, the labelling, the certificates and the UDI strategy.
3. Notified bodies and certificates module
This module is mainly populated by notified bodies. It covers the certificates issued, withdrawn or refused under the MDR and the IVDR, with their essential information.
For manufacturers, the challenge is to verify the consistency between the available certificates, the registered devices and the information declared in the other modules.
Important point: as this module is accessible to the public, the certificates that have been refused for lack of conformity will be visible to the entire market.
4. Clinical investigations and performance studies module
This module concerns clinical investigations for medical devices and performance studies for in vitro diagnostic devices.
It aims to centralise certain procedures and information relating to studies conducted in the European Union. Its mandatory use depends on the rollout timeline applicable to this module. To date, it is still not accessible.
5. Vigilance and post-market surveillance module
This module is intended to enable the management of certain vigilance reports, in particular serious incidents, safety reports and field safety corrective actions.
The planned existence of this module should not be confused with its effective obligation on a given date. As long as the obligations linked to this module are not fully applicable, manufacturers must continue to comply with the procedures and channels required by the competent authorities.
6. Market surveillance module
This module is mainly intended for competent authorities and the European Commission. It is used to coordinate market surveillance activities and exchanges between authorities.
Even if manufacturers do not populate it like a traditional declarative module, the data they enter in EUDAMED may be used in a surveillance context.
How to register in EUDAMED?
Registration begins with the creation of an EU Login account. This is the European Commission’s authentication system that provides access to European services, including EUDAMED.
Once the account is created, the economic operator must submit a registration request in the Actors module. It provides in particular its role, its legal identity, its address, its contact information and the required documents.
The request is then assessed according to the type of actor and the country concerned. After validation, EUDAMED generates the actor’s identifier, generally the SRN for the operators concerned.
Once the SRN is obtained, the manufacturer can continue with the necessary steps in the other applicable modules, in particular UDI/device registration.
The European Commission provides an overview of the registration process: EUDAMED — Actor registration and SRN.
The case of non-EU manufacturers
A manufacturer established outside the European Union must have an active European authorised representative in order to register in EUDAMED.
In practice, the registration request of the non-EU manufacturer must be verified by the authorised representative before being assessed by the competent authority concerned. The manufacturer must also provide a summary document of the mandate, in accordance with the requirements of the EUDAMED process.
It is therefore imprecise to say that a non-EU manufacturer “cannot register” in an absolute sense. It can be registered as a non-EU manufacturer, but its registration involves the intervention of a European authorised representative and validation according to the prescribed circuit.
The mandate must clearly define the operational responsibilities: who prepares the data, who verifies the information, who manages the access rights, who keeps the data up to date and who handles any corrections.
Best practices before submitting the data
Before entering the information in EUDAMED, the manufacturer should prepare a consolidated data set. The information must be consistent across the technical documentation, the EU declaration of conformity, the certificates, the labelling, the UDI data and the commercial information.
It is recommended to clarify internally the user roles in EUDAMED: local administrator, authorised users, persons responsible for data entry, review and validation.
A procedure for keeping the data up to date must also be planned. EUDAMED is not a one-off formality: the data must remain accurate, in particular in the event of a change of address, of authorised representative, of device status, of certificate, of UDI or of product range.
Finally, manufacturers should anticipate validation lead times, particularly when an authorised representative or a competent authority has to intervene.
Key takeaways
EUDAMED has become a central element of MDR and IVDR compliance. It does not replace the regulatory documentation, but it makes visible and interconnected data that must already be under the manufacturer’s control.
Since 28 May 2026, the first four modules are mandatory: Actors, UDI/Devices, Notified bodies and certificates, Market surveillance.
For manufacturers, the starting point is registration in the Actors module and obtaining the SRN. The real work then consists in securing the quality of the data before its submission and organising its ongoing maintenance.