CATimelineAuthorisation object
General timespan (max nr days)
60
For Class III and implantable devices and long-term invasive devices in Class IIa or IIb
Mode of approval (General)
Tacit (Silent)
Explicit approval possible before expiration of time period, provided that the EC has issued a positive opinion
Timespan counted from
Date of notification
Additional Information
Other MDs (Class I, non-invasive, short-term devices in Class II): Notification only – investigations can start provided that favourable opinion from EC in place
