EUDAMED Is Operational: What Medical Device Manufacturers Should Do Now

In simple terms, EUDAMED requieres companies to maintain structured regulatory information in a consistent way across the product lifecycle. The Eudamed database is not just a registration platform; it is a central regulatory infrastructure that connects economic operators, devices, certificates, vigilance data, and market surveillance activities. 

For organizations with solid regulatory processes, quality system controls, and clear data ownership, Eudamed readiness is manageable. The key is approaching the Eudamed database as operational work, not a last-minute registration exercise.

In this article, I’ll outline what is changing, what the main modules and timelines mean in practice, and what medical device manufacturers can do now to build a sustainable approach to compliance.

What EUDAMED is designed to do

The Eudamed database is the European Commission’s IT system developed to implement MDR and IVDR. Its purpose includes, among others:

• Facilitating traceability of devices and strengthening market surveillance
• Supporting compliance for economic operators and notified bodies
• Enabling competent authorities and the Commission to perform regulatory tasks
• Keeping the public adequately informed

The origins of Eudamed go back to an earlier European Commission decision (2010/227/EU), which already defined the database as a tool to reinforce market surveillance. The Commission emphasized that the European database for medical devices should improve oversight by providing competent authorities with rapid access to information on manufacturers and their authorized representatives, devices and certificates, and vigilance data. It was also intended to support the exchange of clinical investigation information and promote the consistent application of reporting obligations across EU medical device legislation.

For manufacturers, this means EUDAMED is part of the compliance infrastructure in Europe, similar to how organizations already manage vigilance, certificates, and UDI requirements today, but with more structure and connectivity.

After the publication of Commission Decision (EU) 2025/2371 of 26 November 2025, the first four modules becomes mandatory from 28 May 2026 onward.

These mandatory modules include:

- Actor Registration (voluntarily available since December 2020)

- UDI/Device Registration (voluntarily available since October 2021)

- Notified Bodies and Certificates (voluntarily available since October 2021, with certain functionalities such as the scrutiny mechanism and CECP becoming fully operational later)

- Market Surveillance

This transition marks the shift of the Eudamed database from voluntary engagement to legally required operational use for core regulatory activities under MDR and IVDR.

The two remaining modules, Vigilance and Post-Market Surveillance, and Clinical Investigations / Performance Studies, are still under development. Unlike the earlier modules, these are not expected to have a voluntary use phase before becoming mandatory. They will apply directly once formally declared functional.

For manufacturers, this means that preparation for the mandatory modules should already be embedded in operational processes, while monitoring further Commission publications regarding the remaining systems.

For teams building familiarity, EUDAMED “Playground” environment is also a useful way to test workflows and understand the system behavior without affecting production records.

If you need assistance using the database or have questions about the reporting process, a detailed guide is available in the EUDAMED Information Center.

It also helps to clarify terminology early, because the terms affect registration expectations:

• Regulation devices are placed on the market in conformity with MDR/IVDR
• Legacy devices are placed on the market under the MDD, and individual sales units may still be placed after MDR/IVDR dates of application
• Old devices are those where the last sales unit was placed before the MDR/IVDR dates of application

One operational detail in the Eudamed database that is easy to overlook is that “device” is interpreted differently depending on context:

• Under MDR/IVDR, “device” refers to each individual device (sales unit)
• In EUDAMED, it refers at the level of the device identifier (UDI-DI)

That distinction influences how manufacturers plan registrations and how they maintain product records over time.

For medical devices placed on the market before the date of mandatory use, expectations can include:

• new sales units of the same UDI-DI
• manufacturer responsibility to demonstrate devices were placed on the market prior
• registration within 12 months from the publication of notice
• no duplicate registration needed
• no registration needed if legacy devices are no longer placed on the market—unless a vigilance action occurs

The practical takeaway is that readiness depends not only on entering information, but also on having controlled records and evidence that supports device status and timing.

Typical triggers for updates include:

• legal entity name changes, address updates, PRRC contact updates, or changes in economic operator roles
• design changes impacting UDI-DI, new SKUs/configurations, discontinuation or market withdrawal
• certificate issuance, amendment, suspension, withdrawal, or scope changes
• new vigilance cases, follow-up reports, status changes, or linked UDI corrections
• PMS report updates, PSUR submissions, PMCF activity updates, and revised risk–benefit conclusions

In practice, medical device manufacturers should plan for EUDAMED updates the same way they plan for other regulated maintenance activities: through clear ownership, defined workflows, and internal controls.

Practical steps medical device manufacturers can take now

EUDAMED readiness is manageable when it is built into existing processes. A few practical steps can make the work more predictable:

1) Treat EUDAMED as part of your regulatory operating model
The goal is not to “complete a database entry,” but to maintain controlled information over time.

2) Establish a source of truth for required data
Define where required data attributes live (RIM, PLM, or another controlled repository).

3) Assign ownership and responsibilities clearly
Be specific about who owns each data field, who maintains it, and who approves changes.

4) Link EUDAMED updates to change control
Maintain EUDAMED data through established change control processes.

5) Include periodic internal checks
Auditors will look for evidence that your process is implemented and controlled over time.