In the #AskArcher blog posts our experts navigate you through the latest regulatory updates for Medical Devices in Europe.
In line with Regulations (EU) 2017/745 and 2017/746, the Commission is required to establish, manage and maintain the European Database on Medical Devices (Eudamed) to provide information on medical devices placed on the EU market. This European database is an essential element of the medical device regulatory framework, ensuring traceability and transparency of medical devices. It was created to register all medical devices placed on the EU market.
Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (IVDs).
The Eudamed database comprises 6 modules, some of which will be publicly accessible: Actor Registration, Unique Device Identification (UDI) and Device Registration, Notified Bodies and Certificates, Clinical Investigations and Performance Studies, Vigilance, and Market Surveillance.
Initially, it was foreseen that the use of Eudamed would become mandatory 6 months after an independent audit had been carried out to confirm the functionality of all 6 modules and after a notice had been published in the Official Journal of the European Union.
In the meantime, the first three modules have been released and can be used on a voluntary basis (Actor Registration, UDI/Device Registration, Notified Bodies and Certificates). It is expected that the development of two other modules (Vigilance and Market Surveillance) will be ready by the end of 2024, while for the last module (Clinical Investigation) this will not be reached until 2026. The mandatory use of each module will start 6 months after it is declared functional following an independent audit and the publication of a Commission notice to that effect in the Official Journal of the European Union.
Because of these delays in the development of the remaining modules, a new Regulation amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) of June 13th, 2024, was recently published in the Official Journal of the European Union on July 9th, 2024.
This new Regulation (EU) 2024/1860 eases the transition to greater transparency by enabling a gradual roll-out of the medical devices database Eudamed and by requiring manufacturers to give prior notice on potential shortages of critical medical devices and IVDs to relevant authorities, health institutions, healthcare professionals and economic operators to whom they supply the devices. It will also help prevent shortages by further extending the transition period for certain IVDs. With this paper, we aim to address the first topic, the roll-out of Eudamed.
Why is this so important?
Waiting for the use of Eudamed until all modules are functional is no longer an option. The new regulation provides for the gradual introduction of the different electronic systems (modules) of Eudamed once their functionality has been confirmed as described above. This gradual mandatory use of each module will speed up and support all key players in the implementation of the regulatory framework (MDR) and enhance transparency for the public.
It also aims to align the dates of application according to the Eudamed requirements with the dates of application according to the requirements relating to national registration. Additionally, this regulation intends to adapt the timeline for applications of the coordinated assessment for clinical investigations, resulting from the delay in the release of the applicable Eudamed module.
What does Archer advise?
At Archer Research, our extensive expertise in the EU MDR requirements allows us to be the best partner for our clients, advising them on how to meet these requirements and timelines. We would like to emphasize, not only to our clients, but to all manufacturers, that:
With this new Regulation, the mandatory use of the first modules of Eudamed is expected starting from Q4 2025.
To facilitate the smooth registration of medical devices in Eudamed before the end of the deadline, manufacturers should already start the completion of the available modules.
They should keep abreast of Eudamed’s progress and especially the implementation of the remaining modules.
In order to facilitate the future mandatory use of the upcoming clinical investigation and vigilance modules, it is advised to familiarize with the Eudamed platform by visiting the Information Centre and the Playground Environment, which currently contains all six modules. This playground environment contains fake data for users to test the different modules and give feedback.
At Archer we are actively diving into the European Commission's dedicated Eudamed page to stay ahead of its progress, enabling us to efficiently support our clients.
If you have questions, concerns, need advice about the EU MDR clinical requirements or need a partner to set up and manage your clinical investigation, feel free to contact us to find out how Archer can support you in your regulatory journey:
Stay connected to Archer for more insights into the medical device landscape!
Roadmap | Current planning for gradual roll out and modules' functionality view
Figure 1: As per the draft timelines (dd 2024) of the European Commission:
Actor, UDI/Devices, Notified Bodies and Certificates and Market Surveillance mandatory use expected from end 2025
Vigilance mandatory use expected from end Q2 2026
Clinical investigation mandatory use: unknown
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