Applicable Directive
“Council Directive 93/42/EEC of 14 June 1993 concerning medical devices” defines Medical
Devices as:
‘medical device’ means 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;
The device is an article intended for the alleviation of disease and does not achieve its
principal intended action in or on the human body by pharmacological, immunological or
metabolic means
Therefore KnS Roll-on is a medical device.
Applicable Directive“Council Directive 93/42/EEC of 14 June 1993 concerning medical devices” defines MedicalDevices as:‘medical device’ means any instrument, apparatus, appliance, software, material orother article, whether used alone or in combination, including the software intendedby its manufacturer to be used specifically for diagnostic and/or therapeutic purposesand necessary for its proper application, intended by the manufacturer to be used forhuman beings for the purpose of:— diagnosis, prevention, monitoring, treatment or alleviation of disease,— diagnosis, monitoring, treatment, alleviation of or compensation for an injury orhandicap,— investigation, replacement or modification of the anatomy or of a physiologicalprocess,— control of conception,and which does not achieve its principal intended action in or on the human body bypharmacological, immunological or metabolic means, but which may be assisted inits function by such means;The device is an article intended for the alleviation of disease and does not achieve itsprincipal intended action in or on the human body by pharmacological, immunological ormetabolic meansTherefore KnS Roll-on is a medical device.
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