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
(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
Applicable national legal framework/ Reference
Annex 10, (2.3.5) LVFS 2003:11
Annex 7 (2.3.5.) LVFS 2001:5
Additional Information
Reporting of SADE and a vigilance report is mandatory for clinical investigation on CE-marked devices used within or outside label + respective combination studies with IMPs, observational investigations on MD and registries.
Annual safety report is mandatory for clinical investigations requiring authorization by CA (CE-marked devices used outside label and non-CE-marked devices and respective combination studies with IMP).
