Article 87 Field Safety Corrective Actions in a third country

L

lizVR

Starting to get Involved
#1
#1
I am hoping for some clarity on Article 87, 1. (b): any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.

Field safety corrective action undertaken un a third country - is this to mean outside of the EU?
In relation to a device which is also legally made available on the Union market - this is clear to be also marketed in the EU
if the reason for the field safety corrective action is not limited to the device made available in the third country - would this be in reference if the FSCA was a lot specific field action impacting only devices sold in the US? If we sell the same device in the EU but the field action did include the EU devices, then I would presume that this third country action is not reportable.
 
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J

Junn1992

Quite Involved in Discussions
#2
#2
lizVR said:
Field safety corrective action undertaken un a third country - is this to mean outside of the EU?
Click to expand...
Yes

lizVR said:
if the reason for the field safety corrective action is not limited to the device made available in the third country - would this be in reference if the FSCA was a lot specific field action impacting only devices sold in the US? If we sell the same device in the EU but the field action did include the EU devices, then I would presume that this third country action is not reportable.
Click to expand...
If your FSCA is for a specific lot that only impacts devices in the US, then you would need to have a documentation record of why lots in the EU are not impacted.

If problem for device occurs for devices placed on the US AND the EU, you would still need to report the US FSCA.
 
L

lizVR

Starting to get Involved
#3
#3
Junn1992 said:
Yes



If your FSCA is for a specific lot that only impacts devices in the US, then you would need to have a documentation record of why lots in the EU are not impacted.

If problem for device occurs for devices placed on the US AND the EU, you would still need to report the US FSCA.
Click to expand...
Thank you for your response on this!
 
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