What is a Medical Device?

Medical Device Definition

A medical device is any instrument, apparatus, implement, machine, implant, in vitro reagent, or other related article which is intended for one of the following:

  • Diagnosis, cure, mitigation, treatment, or prevention of disease or other conditions
  • To affect the structure or any function of the body

A medical device does not achieve its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized for the achievement of its primary intended purposes.

Note: The definition or classification of medical devices will vary depending on the region and its governing body (e.g., U.S. Food and Drug Administration, EU Medical Device Regulation).

What is a Medical Device

FAQs

What is an example of a medical device?

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What is the FDA definition of a medical device?

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When is a device a medical device?

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Why does the FDA regulate medical devices?

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