CAAmendment object

Authorisation mandatory for

Investigations of devices used outside label or without CE mark

Responsible for submission of SA

Sponsor

Additional Information

If the device is used according to CE mark only a notification to EC is required!

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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