Classifying Software - Insulin Calculator

missjenny

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#1
Hello all,

My company has developed a bolus insulin calculator. It is a mobile app that recommends how much insulin the user should take based on the user's recent blood glucose value and planned calorie intake with a consideration of insulin-sensitivity and insulin to carbohydrate ratio, which would be provided by a healthcare professional before first use.

My questions are:
1) Is this IVD or MD?
2) Is this class IIa or IIb?

Reference: MEDDEV 2.1/6

Our consultant has told me that she thinks this is a class IIa MD.

However, I am leaning towards calling it a class IIb IVD as it uses information derived from in vitro examination of a specimen and is intended to be used with a glucose meter, an IVD.

MEDDEV does classify "insulin dosage planning" software as class IIb. I am not sure whether a calculator can be called a planning software since it is not directly connected to an insulin pump.
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Example: radiotherapy planning system used to calculate the dose of ionizing radiation to be administered to the patient, insulin dosage planning stand alone software.
 
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dgrainger

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#2
Hi,

A simple app for calculating an insulin dose would be a class I MD. It may have a higher classification if it is controlling/monitoring or driving/influencing a device with a higher classification.

It could be an IVD if it is an accessory to the BGM.

Regards David.
 

Sarah Stec

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#3
Keep in mind, IVDs aren't classified the same way as medical devices; in other words, you can't have a Class IIb IVD. Blood glucose monitors are a List B IVD.

I think we need a bit more clarification - you say that the app is intended to be used with a blood glucose meter, but then it's not directly connected to an insulin pump. So is there a specific blood glucose meter it's supposed to be used with (as in, does it connect remotely)? Or is it a generic calculator, and it's up to the user to input the information they read off their glucose monitor? Also, like dgrainger said, what are the results used for, and who uses the results? :bigwave:
 

missjenny

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#4
Hi Sarah!

Yes, you are absolutely correct that glucose meters are a List B IVD. Thanks for the clarification.

It is intended to be used with a glucose meter in that the user has to enter a glucose value either manually or via one of our company's Bluetooth connected meters. So, when the user enters them manually, they can use any generic meter, but if they want to connect to a meter, it has to be one of ours but not to any insulin pumps. The users will simply take the information as a recommendation/into consideration when dosing either with an insulin pen or through a pump.

We will specifically mention that it will not be for diagnosing and that they should consult their healthcare professional before setting the calculator.

From all the answers, it seems like it could be either a Class IIa or IIb MD or a List B IVD. But I can't decide... Any more ideas? For what it's worth, the Balansio and MySugr seemed to have received theirs as Class IIb medical devices. However, I was thrown into confusion when my consultant and also notified body suggested IIa. And further into confusion when I started reading the MEDDEV guidance.

Help once more?
 

Sarah Stec

Involved In Discussions
#5
From all the answers, it seems like it could be either a Class IIa or IIb MD or a List B IVD. But I can't decide... Any more ideas?
First, If your NB is saying it's a Class IIa medical device, is there something that gives you a reason not to follow their advice, aside from doing your own due diligence?

Second, I won't get into determining whether your app is an accessory to a BGM; it's a bit confusing for me if I don't have all the info. But you may want to go back to the basics - analyze your product with respect to the definitions of an IVD or a medical device in their respective directives. Very generally speaking, if your app fits the definition of a medical device, and it doesn't have the functions of an IVD (and even then if it does, depending on how your NB and CA interpret the IVDD with respect to software) then it's a medical device. And look at the definitions of "accessory" to see whether your product would fit into that definition.

When considering whether the app is an accessory (which would make it an IVD), consider what effect the calculator has on the functioning of the BGM. If it doesn't affect the BGM at all, meaning the BGM can function as it is intended without the app, then the app may not be an accessory.

You could also ask the competent authority...:bigwave:
 

dgrainger

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#6
The extra information helps - :)

It isn't an IVDMD and the BGM is not assisted by your calculator (unless your own BGMs require it) so it isn't an accessory to an IVDMD.

Implementing rule 2.3 will apply as you are intending that the calculation result is used with an insulin pen or through a pump - IIb.
 

QA-Man

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#7
If this was a stand alone calculator app, it would not be a device at all. Doing the calculations by hand or looking at a chart is the same thing. The fact that it can connect to your device via Bluetooth makes me less certain.

What classification rule did they say it fell under?
 

dgrainger

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#8
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)
 

QA-Man

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#9
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.
 

dgrainger

Trusted Information Resource
#10
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.
 
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