Intended Use vs. Intended Purpose vs. Intended by the Manufacturer - Doubts

thisby_

Involved In Discussions
#1
[FONT=&quot]Hello,

maybe I have a silly doubt, perhaps because I am foreign anyway: in the 2007/47/EC are used 3 expressions: intended use, intended purpose, intended by the manufacturer, do they mean the same thing? the definition of "intended purpose" can be applied to intended use?

[FONT=&quot]Thank you! :)[/FONT][/FONT]
 
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R

rclanzillotto

#2
Re: Inteded use/intended purpose/Intended by the manufacturer - doubts

IMHO...There is no difference in the meanings holding any significance. Best regards
 
P

Phil Fields

#3
Re: Intended use/intended purpose/Intended by the manufacturer - doubts

[FONT=&quot]Hello,

maybe I have a silly doubt, perhaps because I am foreign anyway: in the 2007/47/EC are used 3 expressions: intended use, intended purpose, intended by the manufacturer, do they mean the same thing? the definition of "intended purpose" can be applied to intended use?

[FONT=&quot]Thank you! :)[/FONT][/FONT]
I am not aware of 2007/47/EC, but I have the following suggestions:
Intended Purpose: What function is the device to perform?
Intended Use: How is the device to be used?
These sound like two different questions.

Example: A designer designs a device that surgeon uses during surgery. The device meets the surgeon’s needs for the intended purpose. This device has a removal head that needs to be changed out during surgery.
There are other similar devices on the market with a similar head that unscrew with a right hand thread. The device the surgeon is using has a left hand thread causing delay during the procedure. The device does not meet the surgeon’s intend use.

I hope this helps,
Phil
 

yodon

Leader
Super Moderator
#5
Re: Intended use/intended purpose/Intended by the manufacturer - doubts

And to extend Phil's example...

The intended (use) by manufacturing in this case may be for left-handed surgeons (not that it would really matter, only to illustrate the point). A right-handed surgeon is welcome to use it but it's now an 'off label' use.
 

thisby_

Involved In Discussions
#6
Re: Intended use/intended purpose/Intended by the manufacturer - doubts

First of all thank you so much! :)

I just wanted to be sure, because if a manufacturer gives an intended purpose to the device and the user besides that intended purpose uses it with different intended uses that were not thought by the manufacturer and something happens to the patient who has to respond for that?... the fact that the manufacturer explicited a specific intended purpose but the user gives the device other uses for what the device was not tested, and something happens?

Ex.: Imagine a screen that shows the patient parameters in the doctors' room, but the manufacturer clearly said in the intended purpose that the information in there should be confirm by the devices near the patient, a Doctor that is lazy uses the information there to do diagnosis. Is giving another different use to the device that the manufacturer didn't. If something happens, is the manufacturer guilty because he could thought of it as a possible risk... ?! ( I think it should be, anyway I would like to have your opinion!)

Thank you again!

Emilia
 
R

rclanzillotto

#7
Re: Intended use/intended purpose/Intended by the manufacturer - doubts

Very interesting stuff Emelia

First of all thank you so much! :)

I just wanted to be sure, because if a manufacturer gives an intended purpose to the device and the user besides that intended purpose uses it with different intended uses that were not thought by the manufacturer and something happens to the patient who has to respond for that?... the fact that the manufacturer explicited a specific intended purpose but the user gives the device other uses for what the device was not tested, and something happens?
This is often refered to as off-label use of the device and happens more than we would like to think. Actually Docs are often faced with risk/benefit dilemmas and will go off label to save a seriously ill patient.


Ex.: Imagine a screen that shows the patient parameters in the doctors' room, but the manufacturer clearly said in the intended purpose that the information in there should be confirm by the devices near the patient, a Doctor that is lazy uses the information there to do diagnosis. Is giving another different use to the device that the manufacturer didn't. If something happens, is the manufacturer guilty because he could thought of it as a possible risk... ?! ( I think it should be, anyway I would like to have your opinion!)
Yes should have been mitigated via Risk Management perhaps with product labeling. Hard to say who is guilty or liable. The key is Due Diligence be applied on both sides. However us QA/RA folks are more focused on the device indications than the Docs.
 

thisby_

Involved In Discussions
#8
Re: Intended use/intended purpose/Intended by the manufacturer - doubts

Thank you so much, you really helped me! :)

According to CLASSIFICATION RULE 10 of 2007/47/CE: "Active devices intended for diagnosis are in Class IIa (and continues)..." is this intended for diagnosis an intende use or purpose?

as a manufacturer I know my device can be used for diagnosis, but I didn't say it in my intende purpose, and I make it pass as a Class I device lets say. Can this happen?! Who verifies that actualy it should be a Class IIa device?!

Probably i'm searching for problems that are unreal anyway i would trully like an opinion!

Emilia
 
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thisby_

Involved In Discussions
#9
Re: Intended use/intended purpose/Intended by the manufacturer - doubts

I have read again and I found out that in 2.1. on Annex IX is: "Application of the classification rules shall be governed by the intende purpose of the device" this helps me with my problem!

Emilia
 
R

rclanzillotto

#10
Re: Intended use/intended purpose/Intended by the manufacturer - doubts

Hi Emilia

Yes the intedned use is the intended diagnostic effect. For example TTE Ultrasound is a particular diagnostic mode and an intended use.

However, If the device clinical setting lends itself to being used for diagnosis, I'd seek Classification advice from your local notified body. Good Luck. Rich
 
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