According to the World Health Organization, a "medical device" encompasses any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related articles intended by the manufacturer for use, alone or in combination, for human beings, for one or more specific medical purposes, including:
- 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 through in vitro examination of specimens derived from the human body
A medical device does not achieve its primary intended action by pharmacological, immunological, or metabolic means, in or on the human body, but it may be assisted in its intended function by such means. Products that may be considered medical devices in some jurisdictions but not in others include:
- Disinfection substances
- Aids for persons with disabilities
- Devices incorporating animal and/or human tissues
- Devices for in-vitro fertilization or assisted reproduction technologies
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