CASafetyReporting object
Sponsor
National CA
CA(s) of EU&EFTA Member States concerned
SAE (Serious Adverse Event)
SADE (Serious Adverse Device Effect)
Immediately (without delay)
Quarterly reporting applies to SAEs if a causal relationship with the investigational medical device can be excluded (see additional information)
Only for reportable events occurring in the respective country
SAE reporting form (latest version) for single reports (available on BfArM website).
This PDF-based form is intended for the submission of electronic reports to the BfArM for use by sponsors according to § 3 (6) of the Ordinance on Medical Devices Vigilance (MPSV)
Electronically
Yes
Art 3 (5&6) MPSV/ Ordinance on Medical Devices Vigilance
Art 5 (2) MPSV/ Ordinance on Medical Devices Vigilance (Timelines)
Reportable SAEs from foreign investigational sites (of all other countries where the clinical trial is performed) shall be immediately and quarterly reported on the same cumulative spreadsheet: MEDDEV 2.7.3 Summary Table
NB! New timelines (according to Art 5 MPSV, as amended)
Immediate reporting is mandatory if a causal relationship between the SAE and the investigational medical device, a comparator device, diagnostic or therapeutic procedures performed as part of the clinical trial or other conditions of the trial conduct CANNOT BE EXCLUDED.
Quarterly reporting applies to SAEs if such a causal relationship CAN BE EXCLUDED.