Are You Ready For EUDAMED?

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Are You Ready For EUDAMED?

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EUDAMED is MDR’s one of the most critical aspects as it's intended to act as a “living database” of every medical device that is roaming the European Union. Even though EUDAMED is not fully functional, manufacturers should prepare their plans for its inevitable arrival. The MDCG documents may not be enough to prepare the manufacturers for the practical use of the system. For this reason, EUDAMED BETA was made available to provide technical and guidance documents regarding the EUDAMED system. Furthermore, this section provides access to a playground for EUDAMED.

This playground is a portal that allows users to play around with the EUDAMED system with their company information with no implication to the real system. This system, allows manufacturers to determine their gaps to utilize the system effectively and make plans for its arrival. The current timeline for EUDAMED consists of 6 steps and most of the important ones being the 2024 Q4 which is the deadline for the release of all 6 modules of EUDAMED and making Actors, Vigilance, Clinical Investigation & Performance Studies and Market Surveillance modules mandatory to use. The other one is the 2026 Q2, which is the deadline for making the other modules, UDI/Device, and NB & Certificate modules mandatory to use.

As the purpose of EUDAMED is to create a living database, continuous updates of data will be required from the manufacturers about their devices. Hence, the development time must be used to increase the preparedness level of the manufacturer’s documentation and software integration.


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