Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

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 the module where manufacturer links the device to applicable certificate(s)

The Organisation for Professionals in Regulatory Affairs

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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

The Organisation for Professionals in Regulatory Affairs

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