The EU Commission has published a roadmap to illustrate the current planning for the gradual roll-out of EUDAMED. This roadmap is intended to give the relevant actors estimated timeframes of when each module will become mandatory for use.
According to the roadmap published, the notice for the Actor, UDI/Devices, NB & Certificates and Market Surveillance (MSU) Modules will be published in the OJEU in Q2 of 2025. This means that the mandatory use of these modules will be effective 6 months from this date in Q1 of 2026.
Furthermore, the notice for the vigilance module will be published in Q1 2026, hence meaning that this module will become mandatory as from Q3 of 2026.
It is interesting to note that although there is mention of the Clinical Investigation module, they have only stated the timeframe of when this module will be under development (Q4 2024 – Q3 2036) and there is no mention of when the notice will be published in the OJEU or when it will be made mandatory for use.
The roadmap can be accessed using the following link
