Page Last Updated: 17 July 2024

Where do I log-in to register devices in EUDAMED?

Only manufacturers and System/Procedure Pack Producers have access to register devices in EUDAMED.

To submit device registrations you must have first:

After you have completed the above steps, you will use those same EUDAMED username and log-in credentials to log into the EUDAMED Home Page.

Then click “Register a new Basic UDI-DI” (MDR/IVDR CE marked devices) or “Register a legacy device” (MDD/AIMDD/IVDD CE marked devices), as applicable.

The EU Commission’s UDI/Devices User Guide can be followed for detailed step-by-step instructions. Note that there are two versions available. The user guide titled ‘UDI Devices’ is for ‘Register a new Basic UDI-DI’ in the above image. The user guide titled ‘Legacy Devices’ is for ‘Register a legacy device’ in the above image.

What information is needed in the registration? 

The following details are needed to complete your EUDAMED medical device registration:

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How long does it take to register?

EUDAMED device applications are automatically registered, unless the Basic UDI-DI information needs to be verified by the Notified Body, i.e., registration is immediate for most devices.

EU Commission’s EUDAMED UDI/Devices User Guide states:

“After Submitting the Device, the state of the Device (Basic UDI-DI and UDI-DI) will be:

Annex 1 of the User Guide outlines the types of devices that require confirmation from the Notified Body. Examples are: Class IIb implantable, Class III medical devices, Class C near patient testing IVD devices and Class D IVD devices.

For those above mentioned risk class devices, the registration will be auto-routed to the Notified Body for confirmation, before it can be published in the EUDAMED database.

Please refer to this EU Commission infographic, which outlines the basic steps of the registration process, including the Notified Body’s steps when a certificate must be verified.

How long is the registration valid?

EUDAMED medical device and IVD registrations do not expire. Instead, the registration should be modified as needed. Note that EUDAMED is designed to serve as ‘a living picture of the lifecycle of medical devices that are made available in the European Union (EU).’ Therefore, EUDAMED should be continually updated and maintain current information.

Further, Economic Operators should verify that the data entered into the Actor Registration is correct after the first year. And then every two years thereafter.

Do custom-made devices need to be registered?

No, custom-made devices (CMDs) do not need to be registered in the Devices/UDI module of EUDAMED. This is per Articles 29, 30 and 31 of the MDR, for example Article 29(4):

“Before placing a device on the market, other than a custom-made device, the manufacturer shall enter…in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof…”

While on the surface this seems like good news, the reality is that it complicates the registration requirements for custom-made device manufacturers. This is because Article 21, ‘Devices for special purposes’, states:

“Member States may require that the manufacturer of a custom-made device submit to the competent authority a list of such devices which have been made available in their territory.”

This means that on a case-by-case basis, manufacturers may need to notify the individual competent authorities that they are placing the device on the market.

Additionally, while Class III custom-made implantable devices are exempt from Device/UDI registration, they do require Notified Body certification. The Notified Body must then register the Certificate in EUDAMED. That does not mean, unfortunately, that Class III custom-made implantable devices are therefore exempt from the above mentioned additional local competent authority registrations. This must still be assessed on a case-by-case basis.

The Irish competent authority for example, requires registration of Class I, IIa, IIb and III (non-implantable) custom-made devices via their online form. However, they accept the EUDAMED registration of Class III implantable devices as sufficient, and do not require an additional direct registration through their system. This may not be the case for all national competent authorities.

Do legacy devices need to be registered?

Yes, ‘legacy’ devices are also subject to EUDAMED registration requirements. While most of the MDR/IVDR is not applicable to legacy devices, “registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives” is one of the items applicable.

Read more about: Legacy Devices

What is the deadline to register? 

The deadline to register in EUDAMED has been postponed; therefore, use is currently voluntary.

For the most current understanding of EUDAMED’s implementation timeframe, please read: EUDAMED Gradual Rollout (starting end of 2025)

Even though EUDAMED is currently voluntary, industry is encouraged to start using the system and populating data.

What are the current registration requirements?

Until EUDAMED is 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