CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Sponsor must declare reportable events to

National CA
CA(s) of EU&EFTA Member States concerned

Reportable AEs

ADE (Adverse Device Effect)
SADE (Serious Adverse Device Effect)

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)

National standard reporting form available

European standard SAE reporting form MEDDEV 2.7/3 to be used

Standard Reporting Form

The Guideline MEDDEV 2.7/3 should be taken into account.

Provision of Annual safety report mandatory

Yes

Annual safety report shall be provided by sponsor to

National CA (for interventional clinical investigations on MD: CE-marked, use within or without label & non-CE-marked devices)

Applicable national legal framework/ Reference

Art 22 Decree No 33/2009

Additional Information

SADE: to be reported in all investigations on MD (interventional and observational).
ADE shall be reported in investigations on: CE-marked devices, use outside label + non-CE-marked devices + respective combination studies with IMP.

In general, the Guideline MEDDEV 2.7/3 (responsibilities, timelines and format of report) should 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