Definition of a medical device
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U.S.
A Medical Device is: an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including a component part, or accessory
which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or
any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals,
and which does not achieve any of it's primary intended purposes through chemical action
within or on the body of man or other animals and which is not dependent upon being
metabolized for the achievement of any of its primary intended purposes.
E.U.
A medical device means any instrument, apparatus, appliance, material or other article, whether used alone
or in combination, including the software 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.
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Uploaded March 20, 2005
Last updated March 20, 2005
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