Selling non-CE marked devices for evaluation

#1
Hi all,
Curious as to the legality or regulation on selling non-CE marked devices to a company that wants to perform an evaluation on them. To be clear, they would like to purchase our devices for their own testing and evaluation. We would not be involved or receive any data, etc.

My instinct is that it is not okay and we would have to be involved in the study or evaluation in some capacity.
They have no undergone any kind of clinical testing in recruited humans.

Can anyone shed some light on this?
I'd really just like a good reason to say no to the interested company.

TIA!
 
Last edited:
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shimonv

Trusted Information Resource
#2
Hi milanaro
You did not provide sufficient information, but I would say this - If your product/device was not developed for use in a clinical setting, it should not be used in a clinical study or commercialized in the EC.

If you are a manufacturer of a component or assembly, then in most cases that should not be a problem.

Shimon
 
#3
Hi milanaro
You did not provide sufficient information, but I would say this - If your product/device was not developed for use in a clinical setting, it should not be used in a clinical study or commercialized in the EC.

If you are a manufacturer of a component or assembly, then in most cases that should not be a problem.

Shimon
Thank you Shimon!
For more details that might help- it is a blood collection device (class II). We are manufacturing the device and will submit FDA 510k and CE marking when clinical studies are complete next year. The device will be used in a clinical setting at first with the hopes of transitioning to layperson/home settings in the future.

We've had companies interested in evaluating it internally at their site. My main concern is ethical committee applications and it being used in humans without proper approval.

Does that help or change your opinion?
Many, many thanks!
Best,
Mila
 

shimonv

Trusted Information Resource
#4
Hi Mila,
Okay, so there is no issue with internal testing. If a company takes your device and use it in a clinical trial without proper approval, then they bear the responsibility for "off label" use. I am not a lawyer, but I would make sure the labeling of the device and the business agreement states clearly that it is not approved for human use.
You can check out the interested companies. If they are a large organizations with medical devices in commercial use, they are less likely to do something irresponsible like that.
Hope this helps.

Shimon
 
#5
Hi Mila,
Okay, so there is no issue with internal testing. If a company takes your device and use it in a clinical trial without proper approval, then they bear the responsibility for "off label" use. I am not a lawyer, but I would make sure the labeling of the device and the business agreement states clearly that it is not approved for human use.
You can check out the interested companies. If they are a large organizations with medical devices in commercial use, they are less likely to do something irresponsible like that.
Hope this helps.

Shimon
It very much does - thank you so much! I'm still uneasy about essentially selling a non-CE marked or approved device to a company but your answers really do help. Thank you again!
 
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