EUDAMED is the database developed by the European Commission to centralise and make easily accessible information on Medical Devices and In Vitro Diagnostic Devices (IVDs), as required by the MDR (EU) Regulations 2017/745 and IVDR (EU) 2017/746.

After years of postponement, EUDAMED is finally taking shape, and with it new timelines and obligations for medical device manufacturers. Regulation (EU) 2024/1860 updated the roadmap for the gradual roll-out of EUDAMED, and the completion of the system is estimated by 2027.

The EUDAMED platform consists of six interconnected modules. Currently, three modules (ACTOR, UDI/Devices, Notified Bodies, and Certificates) are active and usable on a voluntary basis to allow manufacturers to adapt in advance and reduce the risk of future delays.

It should also be considered that in 2026, the first modules of EUDAMED are expected to be mandatory: the “Actor” module (ACT) and the “UDI/Device” module (UDI/DEV), the Notified Bodies and Certificates module (NB/CRF) and the Vigilance and Post-Market Surveillance module (VGL). See the update of November 27, 2025.

What are the changes and implications for economic operators about each module?
We will analyse these aspects in the course of the article.

Phased implementation of EUDAMED: what changes?

Article 34 MDR, as amended by Regulation 2024/1860, stipulates that EUDAMED forms become mandatory six months after the publication of the notice of full functionality in the Official Journal of the European Union (OJEU). An independent third-party audit will verify the compliance of the module, following which the official activation notice will be published.

However, there are additional timeframes for registering certain devices and their certificates in EUDAMED. In particular, for legacy devices and those compliant with the MDR and IVDR that continue to be placed on the market after the date of mandatory use of device registration and certificate forms, Regulation (EU) 2024/1860 introduced additional

• 6 months extra time for manufacturers.
• 12 months extra time for notified bodies which, for these devices, will only be required to register the latest version of the relevant certificate and, if applicable, the relevant decision.

The additional timeframes provided for the registration of devices do not apply if, once the use of the vigilance module has also been made compulsory, the devices are subject to:

• PSUR – Periodic Safety Update Report
• Serious accident
• Security Corrective Action
• Trend Report

In these cases, the registration of devices is a necessary and preliminary action to the possibility of using the functionalities of the vigilance module.
In other words, if in the extra period, the vigilance module also becomes mandatory, then the manufacturer cannot wait 6 or 12 months to register the devices: he must register them now before the vigilance module can be used.

The guideline of November 21, 2024 ‘Gradual roll-out of EUDAMED – Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860’ provided important clarifications.

EUDAMED Modules: Features and Timing

1. Actor Registration Module (ACT)
   Allows manufacturers (including those of procedural systems and kits), agents, and importers to register for a Single Registration Number (SRN). Competent Authorities validate the data of economic operators before assigning the SRN number.

• Active voluntarily from December 1, 2020. See the update of November 27, 2025.
• Mandatory six months after publication of the official notice in the OJEU. Obligation is expected in 2026.
• Registration in ACT is also required for operators with legacy devices on the market.

2. UDI/device registration module (UDI/DEV)
   Manages the registration and management of UDI identifiers of devices

• Active voluntarily from October 4, 2021.
• Manufacturers can still register devices in national databases, but the UDI/DEV form, already available voluntarily, will completely replace them six months after the publication of the notice in the Official Journal. Obligation is expected in 2026. See the update of November 27, 2025.
• For devices placed on the market after the date on which the module becomes mandatory: mandatory registration before first placing on the market.
• For devices placed on the market before the date on which the form becomes mandatory: registration within twelve months of publication of the notice in the Official Journal.
• Legacy devices and regulated devices for which individual (sales) units are no longer placed on the market as of the date on which the UDI/DEV form becomes mandatory, only need to be registered in the UDI/DEV form when accidents or corrective safety actions are involved. The same applies to custom-made devices.

Example: A device placed on the market between May 2021 and November 2025 does not need to be registered in EUDAMED if the UDI/DEV module becomes mandatory in 2026. However, if the Vigilance and Post-Market Surveillance (VGL) Module becomes mandatory in July 2026 and the device is subject to supervision in September 2026, registration will be required.

If a vigilance action concerns a legacy device that is not registered as a ‘same device’ that already complies with regulations, it will exceptionally have to be registered in the UDI/DEV module to allow reporting in the Vigilance and Post-Market Surveillance (VGL) module.

The general rule remains: legacy devices do not require registration if ‘the same device’ is already registered.

It is important to note that legacy devices are not subject to the UDI obligations under MDR. However, to enable their registration in EUDAMED, specific unique identifiers, called EUDAMED DI and EUDAMED ID, will be assigned to replace the Basic UDI-DI and the UDI-DI.

3. Notified and Certified Bodies Form (NB/CRF)

It allows Notified Bodies (NBs) to register and manage certificates issued for MDR and IVDR-compliant devices. In addition, NBs must upload the Summary of Safety and Clinical Performance (SSCP) for higher-risk devices.

• Active voluntarily from October 4, 2021, except for the functionality of the examination mechanism and the Clinical Evaluation Consultation Procedure (CECP). See the update of November 27, 2025.
• Certificates issued after the mandatory date: immediate registration.
• Certificates issued before compulsoriness: registration within 18 months of publication in the Official Journal, only if associated with devices registered in the UDI/DEV form.

4. Vigilance and Post-Market Surveillance (VGL) Module
   Manages reports of adverse events, incidents and Field Safety Corrective Actions (FSCA).

• Manufacturers and agents: obligation to report adverse events and FSCA.
• The competent authorities monitor and evaluate corrective actions.
• Not operational; it will become mandatory six months after the publication of the notice of full functionality.

5. Clinical Investigations and Performance Studies Module (CIP)
   Allows the registration and monitoring of clinical studies on Medical Devices and IVDs.

• Competent authorities: approve and monitor studies.
• Not operational; it will become mandatory six months after the publication of the notice of full functionality.

6. Market Surveillance Module (MSM)
   Reserved for Competent Authorities to manage inspections and non-conformities.

• Access is limited to Authorities and, in some cases, Notified Bodies.
• Not operational; it will become mandatory six months after the publication of the official notice of full functionality. See the update of November 27, 2025.

Summary Table