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Selling Medical Demo Devices - is it allowable?

S

snoopy2017

#1
If a company has demo devices, how can they they later resell these devices? do the devices have to be refurbished? what sorts of testing have to be done to be able to sell those devices?
 
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shimonv

Trusted Information Resource
#2
Hi snoopy2017,
There is no format regulation that I'm aware off regarding demo units.
This is more of a quality issue and by that I mean to ask:

1. Is the demo unit identical in any way to the cleared device (design, production, packaging, labeling)?
2. Are you selling the demo unit to the current user or someone else?

If it's exactly the same product and you wish to sell it the current user, then its just a matter of contractual/ financial agreement.

If it's exactly the same product and you wish to sell it someone other than the current user, then you need to refurbish the device according to written procedures. Normally, it's not worth the effort.

If it's not exactly the same device, then you need to justify and validate the differences. I wouldn't go that path.

That's my two cents. Others are welcome to join the discussion.

Cheers,
Shimon
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
That's going to be very much dependent on what the device is.

I wouldn't expect anyone would resell a sample knee implant that has been passed around many hands.
But a digital thermometer? Sure after making sure it still meets acceptance criteria.

It comes down to risk. What's the risk to the patient?
 
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