Would a gel that contains hydrogen peroxide and is designed to be used subgingival and interproximal to control the pathogens that cause gum disease for the treatment of gum disease be considered as a medical device or a medicinal product?

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Published by a ��Ӱ�� Life Sciences expert

Published on: 17 October 2017

Summary

The following facts would support the conclusion that a gel that contains hydrogen peroxide and is designed to be used subgingival and interproximal to control the pathogens that cause gum disease for the treatment of gum disease is a Medicinal Product, as opposed to a Medical device:

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the product is presented as having a medical claim, namely treatment of gum disease
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a judgment of the Court of Justice held that Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code must be interpreted as meaning that, for a substance to be regarded as exerting a ‘pharmacological action’ within the meaning of that provision, it is not necessary for there to be an interaction between the molecules of which it consists and a cellular constituent of the user’s body, as an interaction between that substance and any cellular constituent present within the user’s

Jurisdiction(s):

United Kingdom

Key definition:

Medical device definition

What does Medical device mean?

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for a medical purpose, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body.

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