CASubmissionOfApplication object

Responsible for study submission

Sponsor
Manufacturer acting as sponsor

Prerequisites for submission

Positive opinion by relevant EC(s)
Appropriate insurance

Applicable national legal framework/ Reference

Art 13 Medical Devices Decree (Dutch)
Art 7 of the Dutch decree on active implants)

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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