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Glossary

CND (and EMDN)

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The CND (Classificazione Nazionale Dispositivi medici), developed by the Italian Ministry of Health, is an alternative system to GMDN and has been adopted by the European Commission to help fulfil the regulatory requirements in the new European Union regulations. It is considered suitable for the European Medical Device Nomenclature (EMDN). EMDN is required by the European Commission to be assigned to the device identifier of UDI (UDI-DI) as will be available as part of the publicly available European Union UDI Database (Eudamed) 

Other glossary definitions

S

Significant risk device

An investigational device that:  Is intended as an implant and presents a potential for serious…

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E

End of Trial (EoT) Declaration

Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical…

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