Vomit Bag a Medical Device?

M

Mor628

#1
Hi guys,

I have what seems to be a very silly question. Please help !!

We manufacture vomit bags and want to know if a vomit bag is a medical device? Can we CE mark a vomit bag?
 
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pkost

Trusted Information Resource
#2
A medical device is
any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and 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 or metabolic means, but which may be assisted in its function by such means;
Vomiting is not necessarily the result of a disease, but is a normal bodily function (it can be attributed to a disease though); regardless, a bag does not diagnose, prevent, monitor, treat or alleviate the issue, therefore it is not a medical device

An exception would be if you were intending for the bag to be used to collect the vomit for subsequent analysis, in which case it would probably be an IVD
 

dgrainger

Trusted Information Resource
#5
How does it prevent disease?
That was a hypothetical example of a PPE/MD.

Have a look at the Borderlines manual 1.11-Shoe covers :

"Consequently, shoe covers which are specifically intended by their manufacturer to be used in operating rooms, intensive care units or immunodepressed patients to protect the patient from potential contamination are medical devices. In application of rule 1, they are in class I."

This could apply to a suitably labelled Vomit bag.
 

pkost

Trusted Information Resource
#6
You could, if you wanted, come up with a justification that made the product a medical device (I'm not sure PPE could be justified).

What would be the benefit of making a claim such as "reduces risk of transmitted infection in a clinical setting"? Why would anyone buy your product over a standard vomit bag with no claims? It will presumably cost more, or if not your margins will be reduced with the additional work required to CE mark
 
M

Mor628

#7
Best answer ever! Thank you so much.

Actually, that works out really well for us, because all our products have infection prevention features. And yes, it does cost more than the regular no frills vomit bag.

Thank you, thank you, thank you!
 
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