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What is EUDAMED?


European Database on Medical Devices


The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) [MDR] and in vitro diagnostic medical devices (Regulation (EU) 2017/746) [IVDR].


EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g. manufacturers). In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.


EUDAMED will be composed of six modules related to:



What is the state of play of the implementation of EUDAMED?


The use of EUDAMED is not yet mandatory nor required. Some modules are already available, and can be used voluntarily. However, their use cannot be imposed. In particular:


The mandatory use of the system will start when the entire EUDAMED system (including all 6 modules) has been declared fully functional following an independent audit and a Commission notice to be published in the Official Journal and in accordance with the transitional provisions set out in the medical devices regulations.



Quite Recently, The European Commission published the timeline of when will this system be in place, functional and enforced for mandatory use.


Read more about the EUDAMED Timeline by clicking here


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