The EU Parliament has also adopted the proposal regarding the gradual roll-out of EUDAMED which will facilitate the launch of parts of the Database. This means that the mandatory use of several parts of EUDAMED will start from as early as Q4 of 2025/Q1 of 2026. This gradual roll-out of EUDAMED will help increase transparency … Read more
The EU Commission seemed to have confirmed a delay to the mandatory implementation of EUDAMED by posting a new draft timeline to its website. The draft timeline indicates that all six of the modules will not be in a position to undergo independent audits before Q4 of 2026, this is primarily due to the Clinical … Read more
This month sees an updated EUDAMED, version 2.12 was deployed on 20th September 2023. It is important that all actors keep informed regarding these changes and how they may affect the use of EUDAMED. The release notes detailing new and updated elements can be found here: [Release Notes v2.12] The EUDAMED user guide for Economic … Read more
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