What is EUDAMED?

EUDAMED Definition

EUDAMED is a centralized European database used to collect information about medical devices and their manufacturers. EUDAMED is a key component of the MDR 2017/745 and IVDR 2017/746 regulations. It was designed with the intent to strengthen market surveillance and transparency with regard to medical devices in the EU market. The database provides information related to actor registration, unique device identifier (UDI), device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.


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