ECSafetyReporting object
Adverse Events (AE) - Definitions (pursuant to national law)
SAE: Definition pursuant to Art 2 (5) MPSV (in German only)
Reportable AEs
SAE (Serious Adverse Event)
SADE (Serious Adverse Device Effect)
Reporting timeline
Immediately (without delay)
Additional Information
There is no binding regulation in Germany related to the reporting obligation of SAEs to ECs.
Since ISO 14155 stipulates a declaration of SAEs to ECs, some ECs request a notification (despite lacking the legal basis).
There is no requirement for submission of an Annual Safety report.
NB! SAEs only have to be notified to “Bundesoberbehörde- BOB"
