For the most current information on this topic, please go to our 23 January 2024 post: EU Commission proposes a “gradual roll-out” of EUDAMED, starting in 2025
UPDATED: 7 September 2023 to add information related to EUDAMED Working Group Meeting Minutes
The EU Commission recently removed the EUDAMED implementation timeline chart from its website. No new timeline was uploaded in its place.
This leads to the question: Is EUDAMED being further delayed?
Find below:
The current understanding has been that EUDAMED will be published in the Official Journal of the European Union (OJEU) in mid-2024, then followed by the transition period.
For a full overview of most recent dates published by the EU Commission, please read: New EUDAMED ‘Go Live’ date is Q2 2024
Earlier this month MedTech Insight interviewed Lionel Tussau, who sits as an observer in the MDCG’s EUDAMED Working Group and is Chair of the EUDAMED IT Expert Group for MedTech Europe.
The article, titled “Eudamed: New Dates, Constant Challenges But Light At The End Of The Tunnel”, is available here. Note that you must be subscribed to MedTech Insight to access the page.
Per the interview and article:
“Moves are afoot which should lead to the Eudamed medical device database being substantially fully functional by the end of 2024, resulting in mandatory use of all six modules around mid-2025*…”
“…modules for UDI, certificates and market surveillance, meanwhile, are due to be finalized by February 2024. The audit of these first four modules will start in Q2 2024 as planned…”
“But it is likely to take until the end of 2024 to complete the vigilance and clinical investigation modules. The vigilance module is just over 50% complete at present, and the clinical investigations module has a long way to go and is likely to be finalized by mid-2025…”
The EU Commission has stated that EUDAMED will only become mandatory when all six modules are fully functional. Therefore, until the vigilance and clinical investigation modules are ready, EUDAMED as a whole will not be mandatory.
Further, Tussau confirmed that because the Vigilance & Clinical Investigation modules are so critical, the EU Commission has no plans to put them in production in a voluntary mode. They will only be available when EUDAMED is fully funcational and in production.
That said, ‘fully functional’ may mean it is a Minimally Viable Product (MVP), which will be improved over time. For example, the MVP Notified Body & Certificates module may not initially include machine-to-machine upload functionality.
*EUDAMED is subject to transition deadlines. The Actors, Vigilance, Clinical Investigation & Performance Studies and Market Surveillance modules will become mandatory six months after publication in the OJEU. The UDI/Device and NB & Certificate modules will become mandatory 24 months after publication in the OJEU.
Link to minutes available: HERE
Highlights from the minutes include:
“…the Actor module can be considered finished…the UDI/Devices registration, NBs & Certificates and market surveillance modules are close to be finalised, mainly remain fine tuning and bug fixing.”
“The MVP [Minimally Viable Product] development will need to continue at least for one more year from now (with 2 upcoming releases in 2023 and at least 3 releases in 2024) partially due to the time required to finalise the last module CI/PS [Clinical Investigation/Performance Studies].”
Highlights from the minutes include:
“The Commission presented the delivery plan highlights, the scope of future releases and the steps towards EUDAMED full functionality.
The development will continue for at least one year from now on partially due to the time required to finalise the last module CI/PS [Clinical Investigation/Performance Studies].
“The audit will start in the second half of 2024, and is expected to be completed by end of that year.”
“The Commission will publish a new timeline estimation in the Medical Devices website when available.”
As a reminder, the following steps are required before EUDAMED is mandatory:
The last published timeline (now removed) had the OJEU date as Q2 2024, and the first six-month transition period ending Q4 2024.
Considering the above updated information, it now appears that OJEU publication would not occur until Q1 2025 at the earliest, then followed by the transition periods.
The EU Commission has not formally confirmed new EUDAMED timelines. As noted above, they will publish updated timelines once available. Until then we do not have a solid understanding of the new deadlines. That said, current signs point toward another postponement of EUDAMED, with a new registration deadline of mid-2025.
Stay tuned for further information. Casus will be closely monitoring EUDAMED news, including the official implementation timelines.
