Medical device

Medical device is a term that refers to 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 function by such means.

Classification

Medical devices are classified into Class I (general controls), Class II (special controls), and Class III (premarket approval) by the Food and Drug Administration (FDA) in the United States. The classification is based on the level of control necessary to assure the safety and effectiveness of the device.

Regulation

In the United States, the FDA is responsible for regulating medical devices. In the European Union, the European Medicines Agency (EMA) is responsible for regulation. Other countries have their own regulatory bodies.

See also

• Biomedical engineering
• Medical equipment
• Medical software
• Medical technology

References

Medical device Resources
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