EUDAMED Roll-Out: Timeline, Mandatory Modules and Key Deadlines for Manufacturers
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
EUDAMED, the European Database on Medical Devices, is now entering a new phase.
Since 28 May 2026, four EUDAMED modules have been mandatory to use: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance.
For manufacturers of medical devices and in vitro diagnostic medical devices, this means that EUDAMED is no longer simply a system being gradually introduced. Companies now need to understand which modules apply to them, what information must be registered, and which transitional deadlines may still be relevant.
For a detailed guide to EUDAMED registration requirements, see our EUDAMED Registration: A Comprehensive Guide for Manufacturers.
What is Eudamed?
EUDAMED is the European Database on Medical Devices established under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).
The system is designed to improve transparency, traceability and regulatory oversight of medical devices and IVDs placed on the European Union market.
EUDAMED consists of six interconnected modules covering different areas of the medical device regulatory framework.
The European Commission has implemented these modules progressively rather than making the entire system mandatory at once. Regulation (EU) 2024/1860 established the current framework for this gradual roll-out.
EUDAMED Roll-Out: Where Are We Now?
The first four EUDAMED modules were declared functional through Commission Decision (EU) 2025/2371, published in the Official Journal of the European Union on 27 November 2025.
Under the transitional provisions introduced by Regulation (EU) 2024/1860, this triggered a six-month transition period.
As a result, the following four modules became mandatory to use on 28 May 2026:
- Actor Registration
- UDI/Device Registration
- Notified Bodies & Certificates
- Market Surveillance
The two remaining modules are not yet mandatory. The European Commission currently identifies:
- Vigilance and Post-Market Surveillance – under development.
- Clinical Investigations and Performance Studies – under analysis/development.
The Commission states that these remaining modules will be released when they become mandatory to use, with no voluntary-use period before mandatory use.
EUDAMED Timeline: Key Dates
Understanding the distinction between mandatory use and transitional deadlines for specific registrations is particularly important.
December 2020
The Actor Registration module became available for voluntary use.
October 2021
The UDI/Device and Notified Bodies & Certificates modules became available for voluntary use, subject to certain functionality limitations.
9 July 2024
Regulation (EU) 2024/1860 entered into force. Among other changes, it established the gradual roll-out framework for EUDAMED and introduced related transitional provisions.
27 November 2025
The notice declaring the functionality of the first four modules was published in the Official Journal of the European Union.
This publication triggered the six-month transition period.
28 May 2026
The first four EUDAMED modules became mandatory to use:
- Actor Registration
- UDI/Device Registration
- Notified Bodies & Certificates
- Market Surveillance
28 November 2026
A further important transitional deadline applies to the registration of certain devices in the UDI/Device module.
This deadline should not be interpreted as a general extension of EUDAMED’s mandatory use. The applicable registration date depends on the type and regulatory status of the device and the circumstances covered by the transitional provisions.
28 May 2027
The European Commission’s current transition information identifies 28 May 2027 as the deadline for registering certain certificates issued under MDR/IVDR before the mandatory use of the Notified Bodies & Certificates module.
The Four EUDAMED Modules That Are Now Mandatory
Actor Registration
The Actor Registration module contains information about economic operators covered by the MDR and IVDR, including manufacturers and other relevant actors.
Manufacturers and other actors subject to registration requirements need to establish their registration in EUDAMED. Following validation by the relevant national competent authority, the actor receives a Single Registration Number (SRN).
Actor registration is therefore an important starting point for manufacturers using EUDAMED.
UDI/Device Registration
The UDI/Device module contains information used to identify and register medical devices and IVDs.
The European Commission states that manufacturers must submit the relevant UDI/Device information for devices they place on the EU market.
The module also uses the European Medical Device Nomenclature (EMDN) when devices are registered.
The rules for registering certain legacy devices are also affected by the transitional provisions introduced by Regulation (EU) 2024/1860. Therefore, manufacturers should determine which registration requirements apply to each device rather than assuming that the same deadline applies to every product.
Notified Bodies & Certificates
The Notified Bodies & Certificates module contains information relating to certificates issued by notified bodies under the MDR and IVDR.
This includes information on certificates that have been issued, amended, suspended, reinstated, withdrawn or refused, as well as certain restrictions.
The module became mandatory to use on 28 May 2026.
For manufacturers, it is particularly important that the information needed to support certificate registration is available and consistent with the information held in EUDAMED.
Market Surveillance
The Market Surveillance module supports the exchange and management of information related to market surveillance activities.
Unlike the other modules primarily used by economic operators, this module is principally relevant to competent authorities and the European Commission.
It nevertheless forms part of the first group of four EUDAMED modules that became mandatory to use on 28 May 2026.
What About the Two Remaining EUDAMED Modules?
Not all six EUDAMED modules are mandatory yet.
Vigilance and Post-Market Surveillance:
The Vigilance and Post-Market Surveillance module remains under development.
The European Commission’s current roadmap indicates a possible move towards mandatory use in 2027, but the timeline may be updated depending on the outcome of the relevant audit and implementation work.
Manufacturers should therefore continue to monitor official EUDAMED updates rather than relying on a fixed future date.
Clinical Investigations and Performance Studies:
The Clinical Investigations and Performance Studies module is also not yet mandatory.
The Commission currently describes this module as being under analysis/development.
What Does EUDAMED Mean for Manufacturers?
The mandatory use of the first four modules means that manufacturers should now consider EUDAMED as part of their ongoing regulatory processes rather than as a future project.
For an overview of the EUDAMED registration process and the information manufacturers need to provide, see our EUDAMED Registration: A Comprehensive Guide for Manufacturers.
Depending on their role and products, manufacturers may need to review:
- Actor registration and SRN status
- UDI/Device information
- Basic UDI-DI and device data
- EMDN classification
- information relevant to notified body certificates
- authorised representative information, where applicable
- consistency between EUDAMED records and existing regulatory documentation
- responsibilities for maintaining EUDAMED information within the organisation
The exact obligations depend on the manufacturer’s circumstances, device type and applicable MDR or IVDR provisions.
What Should Manufacturers Do Now?
Manufacturers that have not yet completed the applicable EUDAMED registrations should first establish which registration requirements and transitional provisions apply to their products and organisation.
In particular, manufacturers should not treat 28 November 2026 as a universal deadline for every device. The European Commission’s transitional guidance distinguishes between different types of devices and situations.
A practical review should therefore consider:
- Is the manufacturer correctly registered as an Actor in EUDAMED?
- Does the manufacturer have the required SRN?
- Which devices need to be registered in the UDI/Device module?
- Are the relevant UDI, Basic UDI-DI and EMDN information available?
- Are the applicable certificates and related information correctly reflected in EUDAMED?
- Do internal regulatory records remain consistent with the information submitted to EUDAMED?
Where transitional provisions apply, the applicable deadline should be assessed on a device-by-device basis.
What Happens Next?
EUDAMED implementation is ongoing. Since 28 May 2026, the first four modules have been mandatory, while the remaining modules continue to be developed.
For manufacturers, EUDAMED compliance is an ongoing responsibility. Keeping regulatory data accurate, consistent and up to date is essential as the system evolves and further requirements take effect.
CMC Medical Devices can support manufacturers with EUDAMED registration and MDR/IVDR compliance.
Frequently Asked Questions
Is EUDAMED mandatory?
Yes. Since 28 May 2026, the first four EUDAMED modules have been mandatory to use: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance.
Is the whole EUDAMED system mandatory?
Not yet. The first four modules are mandatory, while the Vigilance and Post-Market Surveillance and Clinical Investigations and Performance Studies modules are still under development or analysis.
What is the EUDAMED deadline of 28 November 2026?
28 November 2026 is an important transitional deadline for the registration of certain devices in the UDI/Device module. It is not a general extension of the date on which EUDAMED became mandatory. The applicable requirements depend on the device and circumstances covered by the transitional provisions.
Do manufacturers need an SRN?
Manufacturers subject to Actor Registration requirements need to register in EUDAMED and obtain a Single Registration Number (SRN) following validation by the relevant national competent authority.
When will the remaining EUDAMED modules become mandatory?
The remaining modules are still being developed. The European Commission’s roadmap provides indicative future milestones, but these dates can change as implementation and auditing progress. Manufacturers should therefore rely on the latest information published by the European Commission.
