Registering Devices in EUDAMED
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October 10, 2021
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October 15, 2021Once your Single Registration Number has been issued, you are ready to move foward with EUDAMED’s UDI/Device registration process.
The EU Commission has published a UDI/Devices User Guide that can be followed for step-by-step instructions.
What information is needed in the registration?
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- Basic UDI-DI
- Authorized Representative, if applicable
- Device classification
- Device Trade Name(s), Model(s), Reference/Catalogue numbers
- CE Certificate details, if applicable
- UDI details: UDI-DI, UDI-PI
- EMDN code
- Where the device is, or will be, marketed
- Device characteristics, such as: single use, sterile, contains latex, storage handling conditions and critical warnings or contra-indications, if applicable
- Company responsible for design, if not the registered manufacturer
- Company responsible for manufacturing, if not the registered manufacturer
Read more about: Basic UDI-DI
Read more about: EMDN codes
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:
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- Registered if the Basic UDI-DI data does not require a confirmation from the Notified Body;
- Submitted if the Basic UDI- DI data requires a confirmation from the Notified Body before being Registered (and being published on the Public website);”
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.
What is the deadline to register?
Currently EUDAMED is voluntary, and its mandatory use date has been postponed multiple times.
For the most current understanding of EUDAMED’s deadlines, please read: New Mid-2025 Implementation Date?
Even though EUDAMED is currently voluntary, industry is encouraged to already start using the system. In the meantime, the device registration requirements under the MDD/AIMDD/IVDD continue to apply: EU Registration Requirements
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 EUDAMED 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.
However, this is only mandatory once EUDAMED is fully functional, and the transition period ends. Per the EU Commission’s timeline document, full functionality is estimated to be Q4 2024. Companies will then have 18 months to upload their data into the UDI/Devices module, i.e., the transition period will end Q2 2026, at which time its use will be mandatory.
All devices, legacy and MDR/IVDR CE marked, may be voluntarily registered at any time. The EU Commission encourages industry to start using the system early.
*Legacy devices are those that have valid CE marking under the old Directives (MDD/AIMD/IVDD) and may continue to be placed on the EU market after the new Regulations come into force, due to the transition period allowance.
Read more about: Legacy Devices
