Is App that motivates patients to do therapy exercises a medical device?

#1
Hi folks,
I'm pretty new to regulatory affairs but would like to understand whether, for the sake of the MDD 93/42/EEC, a mobile app that uses games to motivate patients to do physical therapy exercises at home would be considered a medical device or not?
My understanding is that "motivating" has nothing to do with the actual therapy supply, although it is for the benefit of the patient. But I'm not sure if it may interfere with the "dosage" of that therapy and thus have an influence worth qualifying the app as a medical device.
Any hint on this?

Thanks
 
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Ninja

Looking for Reality
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#2
I would have a hard time understanding how the billboard saying "Drive Sober or get Pulled Over" would be an auto part.
...or a "Top Gun" bomber jacket would be an aerospace part.

At the end of they day, however...I suppose it will be up to the regulatory board...we've all seen sillier things.
 
#3
I'm actually thinking that physical exercises as a therapy can't be regarded as a therapeutic drug... meaning that it won't hurt, I suppose, if a patient would get hyper-motivated by the app and keep exercising more than prescribed (if a prescription has sense at all in such a case).
 
#4
OK, the FDA exercises enforcement discretion for mobile apps of this kind... but what about European regulatory bodies? What the MDD says in regards of that?
 

paulag

Involved In Discussions
#5
Hi,

In the EU, it's all about the intended use. Be very careful with your wording and don't claim any medical scope.

Please don't forget that the MDD (93/42) is going to be replaced by the MDR (medical device Regulation), and there are some changes regarding classification and software there. Make sure to check that out, to also be safe in the changed EU regulatory environment.
 

mihzago

Trusted Information Resource
#6
Actually a physical therapy can hurt, just as lack of, or insufficient therapy can have negative consequences.
This is an interesting case, and there may be a different interpretation depending who you ask. Here are my thoughts.

Whether it's considered a medical device depends on the type of recommendation and how specialized and individualized your advice is. If you provide just a general recommendation using prompts like, "hey, you have not done any therapy for a few days, or your activities are too short", then it's probably not a medical device.
If on the other hand you build upon a therapy prescribed by a physio or GP, and provide specific instruction how to perform these exercises and track progress, then you may fall into a medical device realm.

I recommend you put together a written rationale for your classification, even if you determine it's not a medical device.
As paulag said, the new MDR made some changes to classifications, especially software. I would also not rely much on the FDA's guidance documents and its enforcement recommendations.
 

Ajit Basrur

Staff member
Admin
#7
Hi folks,
I'm pretty new to regulatory affairs but would like to understand whether, for the sake of the MDD 93/42/EEC, a mobile app that uses games to motivate patients to do physical therapy exercises at home would be considered a medical device or not?
My understanding is that "motivating" has nothing to do with the actual therapy supply, although it is for the benefit of the patient. But I'm not sure if it may interfere with the "dosage" of that therapy and thus have an influence worth qualifying the app as a medical device.
Any hint on this?

Thanks
It would if it fits the definition of a medical device

A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
 

dgrainger

Trusted Information Resource
#8
It would depend on the what you claim it can do/intend it to do!
Are you intending it to be used to treat any specific ailments/disease/injury (may be a device) or is it just to improve fitness/wellness/motivation/is a reference manual (unlikely to be a device)?

The definition of a device in MDD 93/42/EEC relates to what the manufacturer claims it does and not how it does it. (it excludes products which "achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means" )
 

Ronen E

Problem Solver
Staff member
Moderator
#9
It would if it fits the definition of a medical device

A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
Sorry, that's the FDA's definition. The OP was enquiring more towards EU regulation.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
The MHRA (the UK’s medical devices regulatory authority) uses the following terms, used by manufacturers, as flags that a mobile app should be considered a Medical Device: calculates, converts, detects, diagnoses, measures, monitors. Further, the MHRA, in its guidance titled Medical device stand-alone software including apps (Aug 2014) stated: “apps with software that monitors a patient and collects information entered by the user, measured automatically by the app or collected by a point of care device may qualify as a medical device if the output affects the treatment of an individual”.

I would recommend formalising and documenting the app's Intended Use, as a basis for the determination whether or not it qualifies as a Medical Device. That documented intended use should form the basis for all labelling (packaging prints, manuals, promotional materials etc.), as well as for verbal promotion / marketing / sales pitch of the app (if any is planned).
 
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