Medical device
Medical devices range from tongue depressors to artificial hearts.
A medical device is any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article intended for medical purposes. Medical devices must be proven safe and effective before marketing, with higher-risk devices requiring more testing and offering greater potential benefit to the patient.
- Earliest known use
- c. 7000–5500 BC
- Earliest known location
- Mehrgarh, modern-day Pakistan
- Us regulation began
- 1902 (Biologics Control Act) and 1906 (Pure Food and Drug Act), with broader oversight in 1938
Lore & Background
Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000–5500 BC at Mehrgarh in modern-day Pakistan, where Neolithic dentists used flint-tipped drills and bowstrings. Study of archaeology and Roman medical literature also indicates that many types of medical devices were in widespread use during the time of ancient Rome. In the United States, early regulation of medical devices began with the Biologics Control Act of 1902 and the Pure Food and Drug Act of 1906, though comprehensive oversight was not established until the Federal Food, Drug, and Cosmetic Act in 1938. Modern regulation and oversight came with the Medical Device Amendments of 1976. Medical device regulation in Europe as known today came into effect in 1993 by the Medical Device Directive, replaced on May 26, 2017, by the Medical Device Regulation.
Reader's Guide
Medical devices vary widely in intended use and indications for use, from simple low-risk devices such as tongue depressors, medical thermometers, disposable gloves, and bedpans to complex high-risk devices that are implanted and sustain life, such as artificial hearts, pacemakers, joint replacements, and CT scans. The design of medical devices constitutes a major segment of the field of biomedical engineering. The global medical device market was estimated between $220 and $250 billion in 2013, with the United States controlling about 40% of the global market, followed by Europe (25%), Japan (15%), and the rest of the world (20%). A global definition for medical device is difficult to establish because numerous regulatory bodies worldwide oversee marketing, with subtle differences in wording preventing global harmonization. Definitions often differentiate medical devices from drugs and recognize in vitro diagnostics as a subclass.
Did You Know?
- Neolithic dentists at Mehrgarh in modern-day Pakistan used flint-tipped drills and bowstrings around 7000–5500 BC.
- The United States began regulating some medical devices with the Biologics Control Act of 1902 and the Pure Food and Drug Act of 1906, with broader authority added by the Federal Food, Drug, and Cosmetic Act of 1938.
- The European Union's Medical Device Regulation replaced the Medical Device Directive on May 26, 2017.
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