Page Last Updated: 23 January 2024

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:

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.

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?

*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.

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How much does it cost 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

Currently EUDAMED is voluntary. 

EUDAMED was originally scheduled to be fully functional by May 26, 2020. However, EUDAMED has been postponed. For the most current understanding of EUDAMED’s deadlines, please read: EU Commission Proposes EUDAMED Gradual Rollout

Why register early?

While the formal compliance date seems distant and use is voluntary, many already expect companies to start registering in EUDAMED. For example, your Notified Body may request proof of your Actor registration (“single registration number”) during an audit.

Further, some Competent Authorities are already requiring use of EUDAMED. For example, the Irish Competent Authority (HPRA) asks manufacturers to register in EUDAMED to fulfil the MDR/IVDR registration requirement, even though use is voluntary. Specifically, they state that:

“The HPRA recognises the voluntary registration module of Eudamed in the absence of a fully functional Eudamed. Once Eudamed is fully functional, this will become the mandatory registration system. The HPRA is therefore requesting that MDR manufacturers, authorised representatives and system and procedure pack producers … to voluntarily register their details on Eudamed to meet the obligations set out in the Regulation.”

Registration requirements until EUDAMED is ready

Until EUDAMED is funcational (and therefore becomes mandatory), the registration requirements under the MDD/AIMDD/IVDD continue to apply.

For an overview of which devices require registration, and where, please read: EU Medical Device & IVD Registration Requirements