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

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

SAE /SADE must be reported

Immediately

National standard reporting form available

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

Standard Reporting Form

European form from MEDDEV 2.7/3 (Guidelines on Medical Devices- SAE Reporting)

Reporting format - Options

Email
To meddev@fagg.be

Provision of Annual safety report mandatory

Recommended

Annual safety report shall be provided by sponsor to

National CA
(not mandatory)

Guidance on AE reporting procedure

Reporting obligations are provided on FAMHP website in section: Human medicines Health Products Medical devices and their accessories Clinical evaluation Adverse events

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
Feedback