ECSafetyReporting object

Reportable AEs

SAE (Serious Adverse Event)
SADE (Serious Adverse Device Effect)

Investigator shall report SAE to

Sponsor

Responsible for AE reporting to relevant EC(s)

Sponsor
Principal Investigator

Guidance on AE reporting procedure

According to MEDDEV 2.7/3 December 2010 (Clinical Investigations: serious adverse reporting (pre CE- mark))

Additional Information

SAE/SADE must be reported to EC(s) for interventional clinical investigations on MD (MD CE-marked, within or outside label; MD without label, respective combination studies).

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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