CATimelineAuthorisation object

General timespan (max nr days)

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


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