Medical Device or not - Throat lozenge

[Rob Udo]

I would like to have your opinoin.

I found the following lozenge with is intended to 'coat the mucous membrane of the throat like balm. In this way, they shield the mucous membrane from dry and polluted air. Mucous membranes, which have already been attacked, are able to recover more quickly and restore their original defensive powers.'

They claim CE marking based on the Medical Device Directive? Where does it fit into the definition of a medical device? Can they apply rule 5 for classifiaction?

Any thougths are welcome.

Rob Udo

[Gert Sorensen]

Originally Posted by Rob Udo

I would like to have your opinoin.

I found the following lozenge with is intended to 'coat the mucous membrane of the throat like balm. In this way, they shield the mucous membrane from dry and polluted air. Mucous membranes, which have already been attacked, are able to recover more quickly and restore their original defensive powers.'

They claim CE marking based on the Medical Device Directive? Where does it fit into the definition of a medical device? Can they apply rule 5 for classifiaction?

Any thougths are welcome.

Rob Udo

Interesting question - and definitely not my field of expertise.

My :
From Wikipedias definition:

Throat lozenge.A throat lozenge or cough drop is a small, medicated candy intended to be dissolved slowly in the mouth to lubricate and soothe irritated tissues of the throat (usually due to a sore throat), possibly from the common cold or influenza. Cough tablets have taken the name lozenge, based on their original shape.

Lozenges may contain benzocaine, an anesthetic, or eucalyptus oil. Non-menthol throat lozenges generally use either zinc gluconate glycine or pectin as an oral demulcent. Several brands of throat lozenges contain dextromethorphan.

Still other varieties[vague] such as Ricola or Halls cough drops contain little more than menthol or peppermint oil and spearmint as their active ingredient, further blurring the line between candy and coughdrops.

Most throat lozenges should be taken in moderation, due to the fact that some active ingredients could be hazardous to the health if consumed in large amounts

So, depending on the ingredients they may be considered to be a medical device? I would think so.

Rule 5:
All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device:
— are in Class I if they are intended for transient use,
— are in Class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class I,— are in Class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in Class IIa.
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class IIa or a higher class, are in Class IIa.

So, provided that we can apply rule 5, then it would be the time that the lozenge took to be completely dissolve the lozenge that determined the class. And, interesting thought, how far the effect of the lozenge travels, past the pharynx or not?

I would never get into something like this without contacting my NB and making sure what the precise interpretation is.

[chris1price]

Hi

If the action of the lozenge is to form a mechanical block as opposed to a medicinal or chemical one, then it is a device. I would suggest they are class 2a, but you should check with your NB or CA.

We are looking at selling a Saline and Heparin Filled syringes for flushing IV lines. These also form a block to infection by the physical presence of saline/heparin in the line; and not by any chemical or medicinal action. These were confirmed as devices by the MHRA.

Chris

[Al Rosen]

Could it be considered a combination product?

[Ajit Basrur]

Originally Posted by Rob Udo

I would like to have your opinoin.

I found the following lozenge with is intended to 'coat the mucous membrane of the throat like balm. In this way, they shield the mucous membrane from dry and polluted air. Mucous membranes, which have already been attacked, are able to recover more quickly and restore their original defensive powers.'

They claim CE marking based on the Medical Device Directive? Where does it fit into the definition of a medical device? Can they apply rule 5 for classifiaction?

Any thougths are welcome.

Rob Udo

Hi Rob,

Can you provide addiutional information regarding this product ?

I know of Actiq® that contains an active called Fentanyl citrate. These are available as lozenges with integral applicator. Additional info is available at ACTIQ

[Dan Armstrong]

Originally Posted by Ajit Basrur

Hi Rob,

I know of Actiq® that contains an active called Fentanyl citrate. These are available as lozenges with integral applicator. Additional info is available at ACTIQ

Fentanyl citrate is nasty stuff. LD50 is 250 micrograms. Not only is it a drug, but it's also a schedule II controlled substance.

[Scott Catron]

Here's the website for these: Engelhard Arzneimittel