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.
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.