Medical Device Industry

The global industry that designs, manufactures and sells medical devices, products intended for medical purposes that achieve their effect through physical rather than chemical or metabolic action, ranging from simple items such as tongue depressors, thermometers and disposable gloves to complex, life sustaining implants such as artificial hearts and pacemakers. The global medical device market was valued at between 220 and 250 billion dollars as of 2013, with the United States accounting for about 40 percent of the market, Europe 25 percent, Japan 15 percent and the rest of the world the remaining 20 percent. The industry is regulated through risk based classification systems, formalized in the United States by the FDA's 1976 Medical Device Amendments and in Europe first by the 1993 Medical Device Directive and later the 2017 Medical Device Regulation, with higher risk devices requiring more extensive testing before manufacturers may market them.