Page Last Updated: 23 January 2024
First, you must have completed your Actor Registration (and obtained your Single Registration Number). If you have not done this yet, then you cannot move forward with the UDI/Device registration process.
After you complete the Actor Registration, you will use your same EUDAMED username and log-in to the same site: HERE
Once you are at this stage of the process, the EU Commission’s UDI/Devices User Guide can be followed for detailed step-by-step instructions. That said, once you click on the option to register a new device, the process is fairly intuitive.
The following details are needed to complete your EUDAMED medical device registration:
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.
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.
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.
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
The deadline to register in EUDAMED has been postponed; therefore, use is currently voluntary. For the most current understanding of EUDAMED’s deadlines, please read: EU Commission Proposes EUDAMED Gradual Rollout
Even though EUDAMED is currently voluntary, industry is encouraged to start using the system and populating data.
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