CATimelineAuthorisation object
General timespan (max nr days)
28
60 (for class III MD and of devices that are implantable or invasive for the long-term as in class IIa and IIb + Registries)
Mode of approval (General)
Tacit (Silent)
Explicit approval possible before expiration of time period
Clock-stop possible if complementary information requested
Yes
Additional Information
Evaluations conducted with devices, that do not belong to the classes mentioned above, do not require a 60 day waiting period.
Combined products (CE-marked MD used within label + IMP): 15 (Phase I) resp. 28 days
![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 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](/media/cms_page_media/2015/11/10/flag_yellow_low_100.jpg)