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?
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?