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

Trusted Information Resource
#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
 
#4
Hi people,
pardon me for intruding but I am sort of dealing with a similar situation and would appreciate your wisdom.

What happens if you have the EXACT SAME device, manufactured by the same OEM and you want to apply for a new CE mark under MDR with another intended purpose?
This client has a surgical scissors used in general surgery, long time on the market with a 510(k) from FDA and PMS & clinical data from MDD.

Now, he wants to get a new CE mark for this same scissors but with an intended purpose exclusively for Obstetrics.
In a previous audit, the NB has reported that use in Obstetrics was off-label and if the device is used in obstetrics it has to be up-classified.

So this client wants to get a CE mark specifically for this specialty. This is doable because this instrument is used by obstetricians for years. My question is: Can they sell the EXACT same device with 2 different brand names, 2 different classes and 2 distinct intended purposes (one for general surgery the other for obstetrics)?
To get certified under MDR this would require 2 distinct TFs?

Any thought are welcome!
 

Raisin picker

Involved In Discussions
#5
Short answer: Yes. Yes.
A medical device is defined primarily by its intended use. You can sell the exact same device as class III (somehow in contact with the CNS), as class II (a/b) and unclassified in the next hardware shop (no medical device). I see this often for marketing reasons with e.g. HA devices (hyaluronic acid used for joints and for the skin).
You can extend the intended use of your current device, or create a "new" device. In the second case, you of course have to provide a new technical file, but can re-use much of the technical documentation.
 
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