ECSafetyReporting object

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

Definition of SAE according to Art 2 (9) Medical Device Act 2010 (en)/ Dz.U. 2010 nr 107 poz. 679 (pl):
A medical event due to which a subject
a) Died
b) Suffered serious deterioration of health (suffered a life-threatening disease or trauma, suffered permanent disability of bodily structure or function, required hospitalisation or extension of hospitalisation, required medical intervention to prevent permanent disability of bodily structure) or function
c) Suffered the death of foetus, threat to the life of the foetus, a congenital defect of labour- related damage.

Reportable AEs

SAE (Serious Adverse Event)
SADE (Serious Adverse Device Effect)
Any events with the potential to influence safety of a subject

Investigator shall report SAE to

Sponsor

Reporting timeline

Immediately (without delay)

Responsible for AE reporting to relevant EC(s)

Sponsor

SAE/SADE must be reported

Immediately (without delay)
Within a max of 7d from the day when the event occurred

National Standard Reporting form available

Yes

Standard Reporting Form

"Form for medical incident notification"/ "Formularz zgłoszenia incydentu medycznego" (in en/pl).
Available on URPL website in section: Wyroby Medyczne » Nadzor Rynku » Formularze.

Applicable national legal framework/ Reference

Art 51 Medical Device Act 2010 (en) / Dz.U. 2010 nr 107 poz. 679 (pl)

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