Once your Single Registration Number (SRN) has been issued, you are ready to move foward with EUDAMED’s Device Registration Module and complete the UDI/Devices registration process. The EU Commission has published a UDI/Devices User Guide that can be followed.
Below is a quick access chart below to guide you through the basic device registration steps for EUDAMED.
Read more about: Basic UDI-DI
Read more about: EMDN codes
EUDAMED device applications are automatically registered, unless the Basic UDI-DI information needs to be verified by the Notified Body.
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.
Currently EUDAMED is voluntary, and its release date has been postponed. Until EUDAMED has a formal date by which it is fully functional , there is no registration deadline that can be quoted. Once EUDAMED is validated as fully functional, then a two-year transition period will take place. EUDAMED medical device and IVD registration will be mandatory by the end of the two-year transition period.
EUDAMED was originally scheduled to be fully functional by May 26, 2020. However, the EU Commission postponed EUDAMED by two years. The new ‘go live’ date was supposed to be May 26, 2022. However, it appears to have been postponed again.
While the EU Commission has not formally announced it, they have quietly posted a new EUDAMED timeline, which shows a Q2 2023 ‘full functionality’ date. After EUDAMED is fully functional, there will be a further two-year transition period for industry to ensure their data is registered into the EUDAMED database. If the timeline in this EU Commission document is met, then that means EUDAMED becomes officially mandatory sometime in Q2 2025.
Even though EUDAMED is currently voluntary, industry is encouraged to already start using the system.
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.
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.
However, this is only mandatory once EUDAMED is fully functional, and the transition period ends. Per the EU Commission’s timeline document, that is estimated to be mid-2025. Considering that MDD/AIMDD CE marked devices can no longer be placed onto the market after 26 May 2024, companies will have MDR CE marking before EUDAMED becomes mandatory.
IVD manufacturers may, however, have a period where there are IVDD legacy devices must be registered in EUDAMED. This is because certain IVDD legacy devices may continue to be placed onto the market until 26 May 2027, which results in a two-year period between when EUDAMED is forecasted to be fully functional and when some IVDD legacy devices can continue to be legally placed onto the market.
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: Legcay Devices