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Classifying Software - Insulin Calculator
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Classifying Software - Insulin Calculator
Classifying Software - Insulin Calculator
Classifying Software - Insulin Calculator
Classifying Software - Insulin Calculator
Classifying Software - Insulin Calculator
Classifying Software - Insulin Calculator
Classifying Software - Insulin Calculator
Classifying Software - Insulin Calculator
Classifying Software - Insulin Calculator
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  Post Number #9  
Old 23rd September 2016, 09:19 AM
QA-Man

 
 
Total Posts: 135
Re: Classifying Software - Insulin Calculator

Quote:
In Reply to Parent Post by dgrainger View Post

QA-Man - this app is software that clearly falls within the definition of a medical device and will be regulated as such in the EU - ("insulin dosage planning stand alone software." is given as an example in the software MEDDEV 2.1/6)
As I said, I was not certain. I imagined the calculator was similar to flow rate calculators for mechanical infusion pumps, which are not medical devices because they do not meet the purposes of article 1.2a. Examples here and here.

I am still curious as to the classification rule the NB said it fell under.

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  Post Number #10  
Old 23rd September 2016, 10:22 AM
dgrainger's Avatar
dgrainger

 
 
Total Posts: 75
Re: Classifying Software - Insulin Calculator

The examples you give would appear to be devices as they have a therapeutic purpose.
They would be classified by implementing rule 2.3:

2.3. Software, which drives a device or influences the use of a device, falls automatically in the same class.
  Post Number #11  
Old 23rd September 2016, 02:49 PM
QA-Man

 
 
Total Posts: 135
Re: Classifying Software - Insulin Calculator

Quote:
In Reply to Parent Post by dgrainger View Post

The examples you give would appear to be devices as they have a therapeutic purpose.
They would be classified by implementing rule 2.3:

2.3. Software, which drives a device or influences the use of a device, falls automatically in the same class.
I disagree. The calculators in the examples I gave do not drive a device or influence the use of a device no more than a pen or piece of paper used to do a hand calculation.

In fact, both of the calculators I posted links to are used widely across the EEA as non-devices.
  Post Number #12  
Old 26th September 2016, 09:03 PM
missjenny

 
 
Total Posts: 43
Re: Classifying Software - Insulin Calculator

Thank you for the thoughtful discussion.

This is another reason why I was having trouble deciding whether it was a Class IIa device or a Class IIb device. I wasn't quite convinced that a bolus calculator app that is independent of insulin pumps and pens could be seen as "insulin dosage planning" software or that it is directly driving or influencing them as the users themselves can decide to not follow the recommended dosage.

However, it does seem like it is a medical device. Just not sure which. And if it is indeed a medical device, then it means I have to find clinical evidence for it which I am quite unfamiliar with as I have only dealt with IVDs in the past. I'm not sure there are much evidence out there for calculators.
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