European Database on Medical Devices (EUDAMED)
The European Database on Medical Devices (EUDAMED) is the EU's centralized IT system for registering devices, manufacturers, certificates, and safety data under the Medical Device Regulation, improving transparency, traceability, and post-market surveillance across European markets.
What is the European Database on Medical Devices (EUDAMED)?
The European Database on Medical Devices (EUDAMED) is the European Union's centralized IT system for registering information about medical devices and the parties involved with them. It is established under the EU Medical Device Regulation as a shared repository for the device ecosystem.
EUDAMED is designed to hold records on devices, manufacturers and other economic operators, certificates issued by notified bodies, and safety-related data. It consolidates information that was previously fragmented across national systems.
Why does the European Database on Medical Devices (EUDAMED) matter?
By centralizing device information, EUDAMED improves transparency and traceability, making it easier to identify a device, follow it through the supply chain, and understand who is responsible for it. This visibility benefits regulators, manufacturers, and the public.
The system also strengthens post-market surveillance by gathering safety and performance data in one place across European markets. That supports faster identification of problems and more coordinated responses when a device raises concerns.
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