EUDAMED goes mandatory: what medical device teams need to know

The European Database on Medical Devices (EUDAMED) has been a long time coming. After nearly a decade of regulatory fine-tuning, its first major compliance milestone is now in sight – and it’s closer than many manufacturers realise.

From 28 May 2026, key parts of EUDAMED will become mandatory under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). But given multiple delays and significant changes to how the system might be rolled out, you may still feel unclear about what’s required.

In this blog, we’ll cut through the confusion by explaining what EUDAMED is for, which requirements are becoming mandatory in May, and what your teams should be doing now.

What exactly is EUDAMED?

EUDAMED is the IT system established under the MDR and the IVDR. Developed by the European Commission, it provides a central database for information about medical devices and in vitro diagnostics placed on the EU market.

The system links key information about manufacturers, supply chain stakeholders, devices, and regulatory certificates. By collecting this information in one place, EUDAMED can help regulators more effectively monitor and respond to emerging safety issues.

According to the European Commission, the system provides a “one-stop shop” to register devices, certificates, and systems and procedure packs across the EU. This, it says, will reduce administrative burden and increase overall sector transparency.

In practice, EUDAMED gives regulators a clearer picture of who is placing devices on the EU market and what those devices are. It’s also important to note that some information submitted to the database will be publicly accessible through its public interface.

What becomes mandatory in May 2026?

When first introduced under MDR and IVDR in 2017, EUDAMED was expected to be fully operational by May 2020. However, technical and regulatory challenges saw that timeline slip multiple times, prompting the European Commission to transition to a phased rollout model in 2024.

This means individual EUDAMED modules only become mandatory once they are declared fully functional. And in November 2025, four of six core EUDAMED modules reached this milestone, triggering a six-month transition period.

From 28 May 2026, use of these four modules becomes mandatory:

• Actor registration

Manufacturers, authorised representatives, and importers must register in EUDAMED and obtain a Single Registration Number (SRN). This links organisations, their devices, and regulatory documentation within the system.

• UDI / device registration

Manufacturers must register devices placed on the EU market using the Unique Device Identification (UDI) framework. This helps regulators find and track devices across the healthcare system.

• Notified bodies and certificates

Notified Bodies must upload information about the certificates they issue, suspend, withdraw, or refuse. This gives regulators and public users improved visibility into device certification status.

• Market surveillance

This module is primarily for EU national regulators, rather than manufacturers. It allows them to more readily share inspection results, safety concerns, and enforcement actions across EU Member States.

The remaining two modules—vigilance and post-market surveillance, and clinical investigations and performance studies—are still in active development. They will become mandatory once they are announced as fully functional.

I’m UK-based—do I need to register?

UK-based manufacturers and suppliers of medical devices that only trade within Great Britain don’t need to register with EUDAMED. However, you must register if your goods are placed on the market within the EU and/or Northern Ireland supply chain.

Quick tips: how to prepare for EUDAMED

For most medical device manufacturers, the challenge will be ensuring your underlying information is ready for submission to the EUDAMED system and its unified database. We recommend taking the time to check the following steps are covered:

• Ensure your organisation is registered

Manufacturers can already register in EUDAMED to obtain an SRN—your EU-wide unique identification number. You can find the necessary declaration forms here, including for non-EU manufacturers.

• Prepare and submit device information

Device data can now be submitted voluntarily through the UDI/device registration hub here. This may include some legacy devices, which you can identify using this handy infographic from the European Commission. But more on that later.

• Check your regulatory data is consistent

Maintain good data hygiene, as data submitted to EUDAMED must align with technical documentation, declarations of conformity, and relevant certificates. This may require an internal review to ensure naming conventions, identifiers, and device data are consistent across systems.

• Get familiar with the system

The European Commission provides plentiful training materials and a test environment to help manufacturers understand how the platform works. You’ll find everything you need to get started here.

What happens next? Preparing legacy devices for EUDAMED.

EUDAMED is part of a broader shift in how the EU oversees medical devices as it moves toward greater transparency between regulators and, where necessary, the public. This includes legacy devices first placed on the EU market before 28 May 2026, which must be registered in EUDAMED by 28 November 2026.

We recommend reviewing your legacy portfolio as early as possible, as the upcoming requirements may expose gaps in organisations with complex, embedded systems. If left unaddressed, you may face difficulties with:

• Justifying post-certification changes

Legacy devices can only remain on the EU market if no significant changes have been made to their design or intended purpose. Without living documentation for firmware updates and version changes, this may be harder to justify.

• UDI complexity for software

Software revisions may form part of the UDI. Continuous Integration/Continuous Deployment (CI/CD) can help automatically tag version changes and generate the necessary documentation.

• Increased regulatory scrutiny

The EUDAMED vigilance module will increase regulators’ visibility into serious incidents and vulnerabilities. Without a secure update and patching strategy, vulnerable embedded systems may face increased regulatory scrutiny and restricted market access.

• Data quality issues

For many organisations, meeting the EUDAMED deadline will likely hinge on the quality, accuracy, and consistency of their data. A thorough, partner-supported software gap analysis can help identify potential gaps or inconsistencies before they occur.

Get ready for EUDAMED with Bluefruit

If you’re unsure how EUDAMED will impact your medical devices, embedded software, and development timelines, our team can help you identify potential compliance gaps—including IEC 62304—and prepare with confidence. Get in touch.