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.
EUDAMED is the European database for medical devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission. It is intended to track the safety and performance of medical devices in accordance with the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).
EUDAMED is accessible to competent authorities as well as economic operators who are registered in accordance with the MDR and IVDR. Economic operators include:
The EUDAMED database consists of six interrelated modules:
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