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A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).[1] Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal means. wikipedia

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 or handicap,
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 or diagnostic purposes by means of in vitro examination of specimens derived from the human body. wikipedia

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 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." US-FDA

A Medical Device (MD)
is defined in Directive (93/42/EEC) as: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the 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 by such means. CE Marking

‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, 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 medical 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 by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. WHO

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