CATimelineAuthorisation object

General timespan (max nr days)

60

Mode of approval (General)

Tacit (Silent)

Timespan counted from

Confirmation of formal completeness

Applicable national legal framework/ Reference

40(2) +40(3) MPG

Additional Information

Explicit approval before expiration of the 60d- timespan is possible.
Clinical investigations of low-risk MDs and performance evaluations of in vitro diagnostic MDs can start once the receipt of a complete and adequate notification has been confirmed by the BASG and the EC has issued a favourable opinion.

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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