Eudamed

EUDAMED is the acronym for the European Database on Medical Devices. It is a comprehensive IT system developed by the European Commission to facilitate the implementation and enforcement of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) in the European Union. EUDAMED aims to improve transparency and traceability of medical devices placed on the EU market.

The primary objectives of EUDAMED are to provide a single point of access for all relevant information concerning medical devices, including their registration, vigilance, clinical investigations, and market surveillance. It serves as a central repository for data submitted by manufacturers, importers, distributors, authorized representatives, and notified bodies. This includes information about the devices themselves, their economic operators, certificates issued by notified bodies, and incidents that occur during the use of medical devices.

EUDAMED is structured into several modules, each addressing a specific aspect of the regulatory framework. These modules cover device registration and unique device identification (UDI), authorized representatives and importers, notified bodies and certificates, vigilance, clinical investigations, and market surveillance. The system is designed to be accessible to various stakeholders, with different levels of access depending on their role.

The implementation of EUDAMED is a crucial step towards strengthening the safety and performance of medical devices available in the EU. By centralizing information and enhancing data sharing, EUDAMED contributes to a more robust regulatory system, ultimately benefiting patients and healthcare professionals. Its full functionality is being rolled out in phases.