ECSafetyReporting object

Adverse Events (AE) - Definitions (pursuant to national law)

An adverse reaction or an adverse event is serious when the administration of any dose from the investigational medicinal product is followed by the death, danger of death, hospital treatment, prolongation of hospital treatment in progress, enduring or substantial health detriment, disability or congenial disorder or birth malfunction of the subject.

Reportable AEs

SADE (Serious Adverse Device Effect)

Responsible for AE reporting to relevant EC(s)

Sponsor

SAE/SADE must be reported

Immediately, not later than 3d (SADE)
Immediately, not later than15d (Any other device deficiency that might have led to SADE)

Provision of Annual safety report mandatory

Yes

Additional Information

Annual Safety report must be provided to EC for clinical investigations on: MD CE-marked use within and outside label, MD without label, respective combination studies with IMPs.

Regarding the AE reporting obligations, the Guideline MEDDEV 2.7/3 (responsibilities, timelines and format of report) shall be taken into account.

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