Reportable

In the case of initial registration and importantly in the context of a new authorisation under the MDR, the immediate reporting of incidents involving medical devices has top priority.

Reportable incidents

Incidents involving medical devices must be reported. When, where and how? An overview.

EUDAMED

The European Medical Devices Database - everything you need to know about it

Reportable incidents

Reportable incidents include all events or behaviour of medical devices that do not correspond to the intended function or use and could be potentially harmful to patient or user. The suspicion of such an occurrence is sufficient for a reportable incident and needs to be reported to the authorities.

EUDAMED

The European Database on Medical Devices (EUDAMED) is a central database for the management of medical devices in the European Union. It was developed to enable the uniform and transparent collection, storage, and provision of information on medical devices.

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