MedTech Insight Article Overview
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.