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Manufacturing and Selling Medical Devices with Used Components

S

sofyMKT

#1
Hi

I wonder if, as medical device manufacturer, I can manufacture and sell devices with already used components (I have validated that the performance and the safety of device are maintained)? Is there any regulations? Do some countries restrict/regulate/prohibit such practices?
I have found information concerning the pre-owned/refurbished regulations but not for this particular case.

Thanks
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

In general, if it doesn't fall under refurbishment, and the used components are validated as acceptable then I'm not aware of regulatory barriers. It's your responsibility to ensure that the resulting device is consistently safe and effective. If you can guarantee that the components meet the specifications (physical, performance, cleanliness etc.), then pre-use should not hold you back. Make sure to identify all issues related to pre-use and then address them all in a robust way.

If you'd be more specific about the pre-used components and the finished device, perhaps we could relate to specific concerns.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#3
Hi

I wonder if, as medical device manufacturer, I can manufacture and sell devices with already used components (I have validated that the performance and the safety of device are maintained)? Is there any regulations? Do some countries restrict/regulate/prohibit such practices?
I have found information concerning the pre-owned/refurbished regulations but not for this particular case.

Thanks
As a manufacturer please look into how you will determine the expected lifetime of such device, which uses used components. This lifetime determines many other responsibilities of you as a manufacturer.
 
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