Adding a medical device in another medical device package

F

François

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#1
#1
Hi all,

Here is the situation.

Our Class IIa medical device's technical file is currently under review by our notified body. It's a single-use sensor to be placed on the chin.

Since, it has been identified that beard could impair the fixing of the device (caution already in the IFU), we would like to offer a skin adhesive to our customer when they purchase the sensor.

The adhesive is a medical device CE marked from another manufacturer. And we will not modify it in anyway.

I see 2 strategies :
1- Include the adhesive in the sensor box. But in my opinion, it's a substantial change since it becomes part of our product, we're introducing new hazards and it could be considered as a critical component (biocompatiblity). So we would have to inform our notified body and update some technical documentation.

2- Place the adhesive within the shipping package together with the sensor. So it's not part of the product. This strategy seems simpler, but I was wondering what would be the consequences. Are we becoming a distributor? Is it a procedure pack?

Do you see a better strategy that would minimize the impact?

Thanks for your advice.
 
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Ronen E

Ronen E

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Staff member
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#2
#2
François said:
2- Place the adhesive within the shipping package together with the sensor. So it's not part of the product. This strategy seems simpler, but I was wondering what would be the consequences. Are we becoming a distributor? Is it a procedure pack?
Click to expand...
(emphasis added)

I think you can go either way - just document a clear decision and be consistent in your implementation.
 
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