What is a medical device?

What is a medical device?

What is a medical device?

To answer the question on what is a medical device we did a little research on the web to develop our answer.

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.”

Taken from http://www.fda.gov/aboutfda/transparency/basics/ucm211822.htm

What is a Medical Device?
The EU Directive for the registration of medical devices defines a medical device as:
’Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:
Diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap,
Investigation, replacement or modification of the anatomy or of a physiological process, or
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.

Taken from http://www.icr-global.org/community/special-interest-groups/medical-devices-special-interest-group/what-is-a-medical-device/

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.
Medical devices vary greatly in complexity and application. Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing, implants, and prostheses. The design of medical devices constitutes a major segment of the field of biomedical engineering.

Taken from http://en.wikipedia.org/wiki/Medical_device

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