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:

E.U.

A 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 for diagnosis and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

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 September 03, 2013
MeddiQuest Limited: Incorporated in England under number 4226188 at BioPark AL7 3AX
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