Module 19 2021

01/06/2021

EUDAMED Modules

Actors

● First to be populated ● Manufacturer, Authorized Representative, Importer, Sponsor ● SRN and SIN issued by Competent authority ● LUA needs to be appointed and named Notified Bodies ● Information on Notified Body and its nominated experts ● Issue of Certificates including refusal, restriction, suspension and withdrawal Devices/UDI ● UDI-DI, Device identifier and UDI-PI, Production identifier ● Both linked back to Basic UDI-DI in database ● Also module where manufacturer links the device to applicable certificate(s)

01/06/2021

IVDeology Ltd | www.ivdeology.co.uk

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EUDAMED Modules

Clinical Investigation ● Sponsor upload information on clinical evaluations ● Competent authorities will also be able to upload data on clinical performance ● Will show adverse events, early termination of studies Vigilance ● As current use ● Also upload trend reports ● Distribution of FSCA Market Surveillance ● Used mainly by CAs and commission with input from Notified Bodies

01/06/2021

IVDeology Ltd | www.ivdeology.co.uk

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