Retrospective Medical Device Certification

[s.parakos]

I was wondering if anybody has had a similar experience and if so how they handled it:

We currently manufacture a device for non-clinical use.
We are about to have our quality system certified and sell the exact same device as a Medical Device.
Our customers who already have the device will want to use them as Medical Devices and will want us to provide them with some form of certification.
Is there anything we can do in this regard without resorting to trading in all the old devices for new ones.

thanks for any advice
Simon

[DannyK]

A lot depends on the classification of the device.
Do you perform the same type of tests when it was not considered a medical device?
Does it have the same label?
I would guess that most QA personnel would be more comfortable with returning the devices to the manufacturer, getting them re-tested, ensuring that all the traceability information is in order and then selling the medical device.