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To overview: SAE and DD report SAE and DD reporting for for eachformance studies SAE and DD reporting for clinical investigations Reget in touch with report Notification interruptions or discontinuations from the supply of the medical device Overview reporting channels Subject corrective actions Portals
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To overview: Efficiency scientific tests of in vitro diagnostic clinical products Halt, Termination or more info Conclusion of a Performance Study Request for waiving the authorisation Authorisation Notification of the Post-Market For everyformance Review Substantial modifications Notifications of for eachformance studies with CDx left-over samples Application for decision on requirement to apshow MD / IVD Chance assessment
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