A
Dear all,
With regards to “MEDDEV 2.12/1 rev.6 Medical devices vigilance system” page 13, it stated:
"Incidents which occurred outside the EEA and Switzerland and led to a FIELD SAFETY CORRECTIVE ACTION relevant to the above-mentioned geographical areas must be reported as a FIELD SAFETY CORRECTIVE ACTION."
If I have a incident outside EEA and Switzerland which lead to a FSCA, who should I send the report to?
Best regards,
Arnthor
With regards to “MEDDEV 2.12/1 rev.6 Medical devices vigilance system” page 13, it stated:
"Incidents which occurred outside the EEA and Switzerland and led to a FIELD SAFETY CORRECTIVE ACTION relevant to the above-mentioned geographical areas must be reported as a FIELD SAFETY CORRECTIVE ACTION."
If I have a incident outside EEA and Switzerland which lead to a FSCA, who should I send the report to?
Best regards,
Arnthor