EUDAMED (European Databank On Medical Devices)
The creation of a European Database on Medical devices (EUDAMED) is one of the key aspects of the new rules on Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g. manufacturers). In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.
EUDAMED will be composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.
EUDAMED Medical Consultancy is always ready to help you manage EUDAMED processes on behalf of your company and the products you manufacture / import.