Medical Device Class I and Class IIa Differences? Inhalator

G

googgic

#1
What is the different between medical class I and IIa. My device is an inhalator which is classed in the directive as class I, is that any chance it will be class IIa???
 
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Al Rosen

Staff member
Super Moderator
#2
googgic said:
What is the different between medical class I and IIa. My device is an inhalator which is classed in the directive as class I, is that any chance it will be class IIa???
You really need to look at annex IX in the MDD to determine your classification. If your inhaler is an active device used to administer medicationit is a class IIa device according to Rule 11 in Annex IX. If you are uncertain, discuss it with a Notified Body.
 
G

googgic

#3
Thank you Al Rosen,
The device is not for medical purpose but it is used as an alternative to alleviate some sickness such as asthma, bronchitis, breathing difficulty, etc. I read through but still confuse though. I may be stupid, coule you tell me what is the difference between invasive and active device.
 

Al Rosen

Staff member
Super Moderator
#4
googgic said:
Thank you Al Rosen,
The device is not for medical purpose but it is used as an alternative to alleviate some sickness such as asthma, bronchitis, breathing difficulty, etc. I read through but still confuse though. I may be stupid, coule you tell me what is the difference between invasive and active device.
In your first post you stated it was class I. Now you say it is not a medical device. I don't quite understand. If it is not a medical device, you don't have to concern yourself with the MDD and classification. The definitions of a medical device, invasive and active are within the MDD.
'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

- diagnosis, prevention, monitoring, treatment Or alleviation of disease,

- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

- investigation, replacement or modification of the anatomy or of a physiological process,

- control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological ormetabolic means, but which may be assisted in its function by such means;
Invasive device
A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the
surface of the body.
Active medical device
Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy.

Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices.
You can download a copy of the MDD from here.
 
G

googgic

#5
:thanx: Thank you Al,
I read through all documents what are hugely gathered on my desk and download and print everything which is possible to make me more clear. I try to understand with my limited English knowledge. I wish I could find this forum last 3-4 month ago when I was wondering. I am not sure my product is medical device or not. It can be and it cannot be. It should be great if you can look through here and please help to let me know whether it is a medical device or not.
I have tried to find this answer for alomost half year and I am really a non expert and novice and I want to do thing right before someone will start charge me for criminal offense. If I do not want it to be medical device which information I should not allow to put on my product.

Thank you for your time so much. I hope your good Karma will be increase. I am a buddhist and I wish you all the best. Good thing will turn around to you as you like to help people, you will never be in trouble.

GOoggic
 

Tim Folkerts

Super Moderator
#6
Googgic,

I'm no expert on medical devices so I can't comment much in that area, but one bit of business advice - hire an editor for the website who is knowledgeable with medicine and knowledgeable with English. When dealing with alternative medicine, credibility is essential. I tend to be skeptical of alternative medicine, so any excuse - like poor grammar or poor wording - can be enough for me to dismiss the product without really looking into the actual merits. It may not be fair to equate the technical expertise of a person with his ability to write in English, but that is the reality. There were numerous cases throughout the website where the intent was clear, but the actual wording was less than ideal. Part of that may be American English vs. British English, but some of it is definitely incorrect English no matter where you come from.

A few dollars (or pounds or Euros) invested in cleaning up the writing could go a long way toward boosting consumer confidence and sales.

Tim F
 
G

googgic

#7
thank you Tim for your comment. I am going to see some English people to edit them for me. Sometimes, it is so difficult to explain in English what I would like to let people know about it. But i will try to improve on it.
 

Al Rosen

Staff member
Super Moderator
#8
googgic said:
:thanx: Thank you Al,
I read through all documents what are hugely gathered on my desk and download and print everything which is possible to make me more clear. I try to understand with my limited English knowledge. I wish I could find this forum last 3-4 month ago when I was wondering. I am not sure my product is medical device or not. It can be and it cannot be. It should be great if you can look through here and please help to let me know whether it is a medical device or not.
I have tried to find this answer for alomost half year and I am really a non expert and novice and I want to do thing right before someone will start charge me for criminal offense. If I do not want it to be medical device which information I should not allow to put on my product.

Thank you for your time so much. I hope your good Karma will be increase. I am a buddhist and I wish you all the best. Good thing will turn around to you as you like to help people, you will never be in trouble.

GOoggic
I think you should find a lawyer experienced in medical devices to review your website and the claims you make for your inhaler.
 
R

Roland Cooke

#9
Re: Difference between Medical Device Class I and Class IIa? Inhalator

Thank you Al Rosen,
The device is not for medical purpose but it is used as an alternative to alleviate some sickness such as asthma, bronchitis, breathing difficulty, etc. I read through but still confuse though. I may be stupid, coule you tell me what is the difference between invasive and active device.
Hi Googic,

As you are based in the UK, I imagine that you are discussing the requirements for selling into that country. (There are posters from all over the world here, classifications are different in different places!)

Firstly, it sounds as if you do indeed need to come back to us with a clear description of the product and its intended use.

The use of clear English is critical, so I would definitely advise getting some assistance with that - however you may be lucky, we have people from all corners on the globe on this forum, you may find there is a native speaker here that can assist with a translation.


As for whether the device is a medical device or not, it sounds from the limited description as if it most definitely is. It may not cure asthma/bronchitis, but if it improves the patient's clinical condition, it would come under the "alleviation of disease" description.

Again, as already pointed out, the clinical evidence would need to be robust (true for any medical device).

An active device is one that is powered by electricity (etc), rather than by gravity or musclepower.

The classification of your device will depend on whether it is invasive and how long it will be used. See Annex IX as discussed (MDD attached).
 

Attachments

Ajit Basrur

Staff member
Admin
#10
Re: Difference between Medical Device Class I and Class IIa? Inhalator

Just an add-on to the great advise given by my friend Roland - a new revision of MDD 93/42/EEC is available and is located HERE
 
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