We are a US manufacturer of CE marked products. If an incident occurs outside of the EU, and has no resulting corrective action, does it need to be reported under the Vigilance System?

Hi
You may find MEDDEV2.12-1 rev 5 useful for guidance. It contains this extract:
"
INCIDENTs which occurred outside the EEA and Switzerland and do not lead to a FIELD SAFETY CORRECTIVE ACTION relevant to these geographic areas do not need to be reported. 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."

I tried to give you the link, but as i am new, I can't post links. So in longhand for D read dot and for FS read forward slash:

ec D europa D eu FS enterprise FS medical devices FS meddev FS index D htm

Hope that helps
QT

Hi
You may find MEDDEV2.12-1 rev 5 useful for guidance. It contains this extract:
"
INCIDENTs which occurred outside the EEA and Switzerland and do not lead to a FIELD SAFETY CORRECTIVE ACTION relevant to these geographic areas do not need to be reported. 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."

I tried to give you the link, but as i am new, I can't post links. So in longhand for D read dot and for FS read forward slash:

ec D europa D eu FS enterprise FS medical devices FS meddev FS index D htm

Hope that helps
QT

Here is the link.

http://ec.europa.eu/enterprise/medical_devices/meddev/index.htm

Stijloor.