Page Last Updated: 2 July 2026

What exactly is EUDAMED?

EUDAMED is the European Database on Medical Devices. It is similar to other public government databases, such as the US FDA’s database, which contains all registered Establishments, 510(k)s and pre-market approvals, device listings, adverse events/recalls, clinical investigation data, and more.

EUDAMED aims to consolidate medical device and IVD information into a central databank, and is referenced throughout the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR).

EUDAMED is designed to contain information such as:

• registration of economic operators (specifically: manufacturers, system/procedure pack producers, authorized representatives, and importers)
• registration of devices
• CE marking certificates
• clinical investigations
• vigilance and market surveillance

Most of the data will be publicly available, and it is obligatory that all responsible parties populate the database with the appropriate information.

How is EUDAMED Structured?

EUDAMED will be comprised of six* different modules.

1. Actor registration
2. UDI/Devices registration
3. Notified Bodies and Certificates
4. Clinical investigations and performance studies
5. Vigilance and post-market surveillance
6. Market surveillance

Modules are simply different sections of EUDAMED. For example, to search for registered medical devices, go to the EUDAMED public website and then click on the “Devices” box. This is one module of EUDAMED.

*The first three modules are already available for use on a voluntary basis. The remaining modules are pending release.

How does EUDAMED relate to CE Marking?

Registration in EUDAMED is separate from EU approval/conformity assessment, i.e., CE Marking. EUDAMED is intended for tracking and transparency purposes; it is not an approval system.

Companies must first obtain CE Marking for their device. Then they can register that device into EUDAMED.

What are the steps to register in EUDAMED?

1. First, create a new EU log-in account here:EUDAMED restricted site
2. Then, submit your company registration, following the Actor* Registration steps.
3. Last, after the Actor registration is complete, manufacturers can register their products in EUDAMED, following the UDI/Devices Registration steps.

*Once your Actor (i.e., company) registration is approved, you will be issued a EUDAMED Single Registration Number (SRN). This SRN is needed for Notified Body applications, and is listed in your technical documentation, such as the Declaration of Conformity.

Is there a fee to register in EUDAMED?

EUDAMED is completely free of charge. This is unlike many other government systems, which charge fees for new registration and/or maintenance of the registration listing, such as the US FDA, UK MHRA, Singapore HSA, Australian TGA, among others.

Deadline to Register in EUDAMED

EUDAMED became mandatory starting 28 May 2026. Devices that were already marked in Europe before this date have a further 6-month transition period, and must be registered by 28 November 2026.

Note: in addition to EUDAMED registration, some EU member states still require a separate registration submitted for their individual market. For an overview of which markets require this dditional registration, please read: EU Medical Device & IVD Registration Requirements

EUDAMED Reference Guide

This quick-reference guide consolidates all essential access points, registration checklists, common troubleshooting solutions, and data upload methods. It saves you from having to search through scattered Commission documentation to find what you need.

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