Same intended use devices - Technical file

#1
A technical file has been submitted to device #1 and we got notified body approval.
This device measures temperature on the forehead, and intended to hospitals.
Now we want to submit another device that measures temperature on the wrist.
The differences between both:
Device #1 has an bio-adhesive, device #2 will have a strip
Second difference is the location - device #1 forehead and device #2 wrist
Third difference is the user - device #1 hospital and device #2 home
Do we need to submit a new technical file for device #2?
If not, what is required to submit?
 
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shimonv

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#2
If the intended use for device 1 is different than the intended use for device 2, you need a new Technical File for it.
The fact that one is intended for hospitals while the other for home use is a pretty big difference. Furthermore, the V&V and labelling for device 2 is going to be be different than device 1.
So, it seems to me that you have to submit a new technical file.

Shimon
 
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