CASubmissionOfApplication object

Responsible for study submission

Sponsor
Legal representative domiciled in the respective country

Prerequisites for submission

Positive opinion by relevant EC(s)

Guidance on submission of application available

Yes

Guidance on submission of application

A guideline providing detailed guidance on format, content and required appendixes of application is available (Guidance on The Format of Application Form for Medical Device Clinical Trials [to The Ministry]).

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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