Medical devices

Medical devices are instruments, apparatuses, implements, machines, appliances, implants, reagents for in vitro use, software, materials, or other similar or related articles, 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[edit | edit source]

Medical devices are classified into Class I (general controls), Class II (special controls), and Class III (premarket approval).

Regulation[edit | edit source]

In the United States, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices. The European Union Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) have been introduced to ensure high standards of quality and safety for medical devices.

References[edit | edit source]

Medical devices Resources
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