European Database on Medical Devices (EUDAMED)

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The European Database on Medical Devices (EUDAMED) is a secure online platform developed by the European Commission to support the implementation of the new EU medical device regulations (MDR and IVDR). EUDAMED serves as a central repository for information related to medical devices, including registration of economic operators (manufacturers, authorized representatives, importers, and distributors), submission of clinical data, and reporting of adverse events. EUDAMED also includes a device identification module, which provides a Unique Device Identifier (UDI) for each device, and a Certificate and Notified Body module, which lists the certificates issued by notified bodies and the activities for which they are designated. EUDAMED will become fully operational in May 2022, after a series of phased rollouts.