Vigilance Report Required for Incidents Outside the EU?

[jdy11]

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?

[Quali-Tee]

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

[Stijloor]

Originally Posted by Quali-Tee

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/medic...ddev/index.htm

Stijloor.