S
SMCM94
Hello all. I am in need of a bit of assistance.
Our organization recently acquired a medical device originally manufactured in Italy. During the transition process, I have discovered that the OEM maintained that a device retained it's "new" status for a period of 12 months once the original shipping carton has been opened. This is not the problem.
The hic-up comes when a "new" machine is returned prior to the 12 month period and then returned to the field, perhaps to a different customer. For example, a device could be shipped to a customer, who for one reason or another, decides not to keep the machine after 3 months. The device is returned, refurbished, and repaired, if necessary. That same device can than be sold or leased to a different customer as "new" with only 9 months remaining on the warranty for the new device.
I am concerned that there are regulatory and/or legal implications with labeling the returned device as "new" but I have not been unable to find any regulatory or legal guidance on this matter. So, I have nothing to support me when going up the ladder or am I just off base?
Any assistance would be greatly appreciated. Thank you.
Our organization recently acquired a medical device originally manufactured in Italy. During the transition process, I have discovered that the OEM maintained that a device retained it's "new" status for a period of 12 months once the original shipping carton has been opened. This is not the problem.
The hic-up comes when a "new" machine is returned prior to the 12 month period and then returned to the field, perhaps to a different customer. For example, a device could be shipped to a customer, who for one reason or another, decides not to keep the machine after 3 months. The device is returned, refurbished, and repaired, if necessary. That same device can than be sold or leased to a different customer as "new" with only 9 months remaining on the warranty for the new device.
I am concerned that there are regulatory and/or legal implications with labeling the returned device as "new" but I have not been unable to find any regulatory or legal guidance on this matter. So, I have nothing to support me when going up the ladder or am I just off base?
Any assistance would be greatly appreciated. Thank you.