Definition of disease as per medical device defintion

[sriramsl]

Dear all

The definition of Medical Device uses the term "disease" - as in "diagnosis, prevention, monitoring, prediction, prognosis, treatment o ralleviation of disease". I understand that normally we refer to disease as given in dictionary "any harmful deviation from the normal structural or functional state of an organism, generally associated with certain signs and symptoms and differing in nature from physical injury".. This is clear and I do not have any confusion here.

However, I would like to know is there any definition of 'disease" given by any Regulation (particularly EU Regulation) in the context of Medical Device definition.

This question has arisen, because one the companies that has designed a "customised software application that depicts the medical condition of a patient and the treatment procedure - particularly sugical procedure - in a video form - to be used by clinician to explain the medical procedure to the patients, and this company claims that it is a medical device, since it "alliviates the anxiety or fear of a patient of the impending surgery" and considers "anxiety or fear as a disease"

From the dictionary definition quoted above, I do not think that anxiety will fall under the definition of disease, though it may be considered as 'emotional or psychological disease or disorder" .

Hence I will appreciate if anyone can guide me to the definition of "disease" as per the medical device definition

Thanks and Regards
Sriram

 

[Ed Panek]

First since your device is completely passive and educational only I think whichever pathway chosen regulators wont ask too many questions about it.

Since the company claims it treats anxiety, how does the evidence for that claim discuss anxiety? Do you have acess to that?

 

[Tidge]

Since the company claims it treats anxiety, how does the evidence for that claim discuss anxiety? Do you have acess to that?

It would also be very interesting to see the benefit-to-risk analysis of such a device.

 

[Al_Z1]

Hm, I'd try to ask this company about compliance of their anxiety or fear as a disease with The International Statistical Classification of Diseases and Related Health Problems. 11th revision (ICD-11)...As blunt, as possible.

 

[sriramsl]

First since your device is completely passive and educational only I think whichever pathway chosen regulators wont ask too many questions about it.

Since the company claims it treats anxiety, how does the evidence for that claim discuss anxiety? Do you have acess to that?

Thanks Ed for the reply....

My question is - what is the definition of disease as per Medical device definition. Will appreciate if you can answer that

Thanks
Sriram

 

[sriramsl]

Hm, I'd try to ask this company about compliance of their anxiety or fear as a disease with The International Statistical Classification of Diseases and Related Health Problems. 11th revision (ICD-11)...As blunt, as possible.

Thanks AI_Z1 - let me chek the ICD-11 for definition of disease
However, how does Medical device definition - define disease?

Thanks
Sriram

 

[dgrainger]

I haven't seen a definition of 'disease' in device regulation/guidance at an EU level.

It is defined in UK's medicines regulations:

​

"'Disease' includes any injury, ailment, or adverse condition, whether of body or mind." (Human Medicines Regulations 2012, SI 2012/1916, reg 8(1))​

This is UK's implementation of Directive 2001/83/EC (which doesn't contain a definition!)

 

[sriramsl]

Hm, I'd try to ask this company about compliance of their anxiety or fear as a disease with The International Statistical Classification of Diseases and Related Health Problems. 11th revision (ICD-11)...As blunt, as possible.

Dear AI_Z1
Thank you for referring me to ICD-11
There is a category "Anxiety or fear-related disorders, unspecified" with code 6B0Z and Anxiety or fear-related disorders, specified with a code 6B0Y..
So the Anxiety or Fear due to the impending medical treatment can be taken in to this category of Mental "disease" and hence the product can be classified under Medical Device with an intended purpose of "Alleviating the mental disease of anxiety due to impending medical treatment"

 

[sriramsl]

I haven't seen a definition of 'disease' in device regulation/guidance at an EU level.

It is defined in UK's medicines regulations:

​

"'Disease' includes any injury, ailment, or adverse condition, whether of body or mind." (Human Medicines Regulations 2012, SI 2012/1916, reg 8(1))​

This is UK's implementation of Directive 2001/83/EC (which doesn't contain a definition!)

Thank you dgrainger
Since the UK medicines regulation identifies "mind" in the definition of disease, then the anxiety can be taken as a mental disease....

Thanks
Regards
Sriram

 

[Ed Panek]

Stop thinking disease. A broken bone isn't a disease but it is a medical condition. Pain isn't a disease, but try to put pain reliever on a home brew of herbs you made and sell it.

A device that reduces anxiety is a medical claim. Anxiety is defined here as a disorder. Table 3.15, DSM-IV to DSM-5 Generalized Anxiety Disorder Comparison - Impact of the DSM-IV to DSM-5 Changes on the National Survey on Drug Use and Health - NCBI Bookshelf (nih.gov)

What this means is doctors diagnose this "disease" or condition and treat it using drugs and devices to help. If you claim you can help, you are now tied into treating anxiety. That requires evidence.