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Does oral irrigator fall within the scope of Medical Device Directive 93/42/EEC?

Roland chung

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#1
Hi all,

Oral irrigator (also called dental water jet) uses a stream of pulsating water to remove plaque and food debris. Does this device fall within the scope of Medical Device Directive 93/42/EEC?

Thanks,
Roland
 
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pkost

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#2
I held off responding as I hoped someone else would be able to give a more confident answer.

If it is limited to removal of food and plaque I would err towards saying it is not a medical device - I don't believe plaque is considered a disease and I don't think it is really possible to make a leap to say that it prevents a disease from developing.

If you say it is specifically for people with gingivitis or similar then it would probably become a medical device

I'm not confident in my answer and would suggest that you contact your competent authoritiy to ask for their advise!
 

Mikishots

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#3
Where I live (Canada), it's a medical device.

Directive 2007/47/EC (which amended 93/42/EEC) defines a medical device as (paraphrasing): Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, 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
It's primarily marketed to prevent and treat gingivitis, which is defined as a non-destructive periodontal disease.
 

pkost

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#4
I agree, but if the marketing does not mention gingivitus then I'm still inclined to say it is not a medical device.
 
S

SteveK

#5
Toothbrushes, floss, interdental brushes and similar dental hygiene products all have a ?therapeutic? effect as per an oral irrigator. These are NOT necessarily classified as medical devices under the MDD (certainly, toothbrushes are not), so I believe (as per pkost) that they are also not likely to be seen as medical devices. However, I have seen packaging for irrigators that carry the CE mark (with no number) ? but this could be for compliance to the low voltage equipment directive, or indeed some companies DO see them as (Class I) medical devices.

To confuse matters further, there are many dental items in the MHRAs (UK) Class I medical device database including Dentifrice (i.e. toothpaste) and mouthwash products. There is also a listing in this database (MHRA Class I code Z119) for a ?Dental Instrument (Invasive & Transient Use)?. I suppose an oral irrigator could be classed as such - but so could a toothbrush, which as I pointed out, toothbrushes are NOT medical devices.

Sorry to muddy the waters.

Steve
 
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