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)
SUSAR being life-thereatening or leading to death must be reported
Within a max of 2 d upon first knowledge for events being fatal, life-threatening, or deteriorating health
No later than 2 calendar days after awareness by sponsor
All other SUSARs
Within a max of 7 d upon first knowledge (+8d for additional information) for events being life-threatening or leading to death
No later than 7 calendar days after awareness by sponsor
SAE /SADE must be reported
Immediately
(Reportable events must be fully recorded)
National standard reporting form available
European standard SAE reporting form MEDDEV 2.7/3 to be used
Provision of Annual safety report mandatory
Yes
Annual safety report shall be provided by sponsor to
National CA
CA(s) of EU&EFTA Member States concerned
Applicable national legal framework/ Reference
Regulation of 15 December 2005 no 1690 on medical devices, Annexes AIMU VII and ØMU X (no)
