Medical Device - Versatile In Vitro Diagnostic Instrument, Non-pharmacological Application For Disease Diagnosis And Treatment

Medical Device: (according ISO 13485)

Any instrument, apparatus, implement, machine, appliance, implant,
in vitro reagent or calibrator, software, material or other similar or
related article, intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific
purpose(s) of diagnosis, prevention, monitoring, treatment or
alleviation of disease, diagnosis, monitoring, treatment, alleviation
of or compensation for an injury, investigation, replacement,
modification, or support of the anatomy or of a physiological process,
supporting or sustaining life, control of conception, disinfection of
medical devices, providing information for medical purposes by means of
in vitro examination of specimens derived from the human body and which
does not achieve its primary 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.



Medical device (according to European Union medical devices directive)
For the purposes of Directive, the following definitions apply:



(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 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;



(b) accessory means an article which whilst not being a device is
intended specifically by its manufacturer to be used together with a
device to enable it to be used in accordance with the use of the device
intended by the manufacturer of the device;

Medical device Definition (according to US FDA)

A 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 its 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."