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
