CATimelineAuthorisation object

General timespan (max nr days)

60

Mode of approval (General)

Explicit
In case the CA fails to issue its decision within the timeline, the conduct of the clinical investigation shall be considered authorised

Timespan counted from

Date of submission of valid application

Applicable national legal framework/ Reference

Section 15 of Act No 268/2014 on Medical Devices

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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