Module 15 Presentations

10/04/2024

Transparency

EUDAMED – EU Database on Medical Devices-clinical

 The databank shall contain the following:-  Clinical Investigations (sponsors, description of investigational device, status, adverse events)  Vigilance and post-market surveillance (serious incidents, FSCA, periodic summary reports, trend reports FSN+ Periodic Safety Update Report)  Market surveillance (surveillance activities, devices presenting an unacceptable risk, non-compliant products, preventive health protection measures)

 Data shall be entered into Eudamed by:-  Member states, Notified Bodies, Economic Operators, Sponsors

The Organisation for Professionals in Regulatory Affairs

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ISO14155:2020 “Clinical investigation of medical devices for human subjects - Good Clinical Practice”

The Organisation for Professionals in Regulatory Affairs

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