What is EUDAMED?

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

EUDAMED is intended to centralize medical device and IVD information into a single databank, and it is referenced throughout the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR).

EUDAMED is structured to include information such as:

– economic operators’ registration (specifically: manufacturers, system/procedure pack producers, authorized representatives, and importers)

– device registration

– CE marking certificates

– clinical investigations

– vigilance and market surveillance

Most of the data will be publicly accessible, and all responsible parties are required to input the database with the appropriate information.

EUDAMED structure

The structure of EUDAMED is organized into six different modules. These modules include actor registration, UDI/Devices registration, Notified Bodies and Certificates, Clinical investigations and performance studies, Vigilance and post-market surveillance, and Market surveillance. Modules are distinct sections of EUDAMED. For instance, to find registered medical devices, you can visit the EUDAMED public website and select the “Devices” box, which represents one module of EUDAMED. The first three modules are currently available for voluntary use, while the remaining modules are awaiting release.

How is EUDAMED connected to CE Marking?

Enrollment in EUDAMED is distinct from EU approval or conformity assessment, such as CE Marking. EUDAMED is designed for tracking and transparency, and it is not a system for approval.

Companies are required to acquire CE Marking for their device before registering them in EUDAMED.

What are the steps to register in EUDAMED?

First, create a new EU log-in account here: EUDAMED restricted site.
Continue with company registration, follow the Actor* Registration steps.
If the Actor registration is complete, following the UDI/Devices Registration steps, manufacturers can register their products.

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

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, and Australian TGA, among others.

Registering in EUDAMED

At this moment, listing on EUDAMED is voluntary. EUDAMED was originally scheduled to be fully functional by May 26, 2020; it has been postponed. For the most current understanding of EUDAMED’s deadlines, please read EUDAMED Gradual Rollout (starting 2025).

What are the benefits of registering early?

Although the official deadline for compliance may seem far off and participation is currently optional, it is widely anticipated that companies will soon be expected to begin registering in EUDAMED. For instance, your Notified Body might require evidence of your Actor registration (referred to as the “single registration number”) when conducting an audit.

Some Competent Authorities are already mandating the use of EUDAMED. For instance, the Irish Competent Authority (HPRA) is requesting that manufacturers register in EUDAMED to fulfill the MDR/IVDR registration requirement, despite the voluntary nature of the system.

They specifically state:

“The HPRA acknowledges the voluntary registration module of Eudamed in the absence of a fully operational Eudamed. Once Eudamed is fully operational, this will become the obligatory registration system. The HPRA is urging MDR manufacturers, authorized representatives, and system and procedure pack producers to voluntarily register their details on Eudamed to fulfill the obligations outlined in the Regulation.”