Dit artikel wordt geciteerd in 1 The Need for a Regulatory Framework for Healthcare Products Medicines and medical devices have been in existence for centuries. According to the literature, there is evidence that scalpels, slings, splints, crutches and other medical devices were used as long ago as BCE by the Egyptians.
Neither drugs nor medical devices are ordinary consumer products. In most instances, consumers are not in a position to make decisions about when to use them, which to use, how to use them and how to weigh potential benefits against risks as no medicine or device is completely safe. While the concept of ensuring their quality has evolved gradually over time, the modern health products regulation started only after breakthrough progress in the nineteenth century, especially in chemistry, physiology and pharmacology.
Historically, countries have tended to introduce regulation or tighten existing regulation only when forced to do so by a public outcry over an unexpected and unfortunate event.
Inthe death of over Americans who had taken a cough mixture containing an antifreeze-type chemical facilitated the introduction of pre-market testing to their medicinal regulatory requirements.
Later, in the s, with the thalidomide incident, a tranquilliser and sleeping pills that caused phocomelia in newly born children as a side effect,2xResulting in the shortening or absence of limbs.
Medical devices: Better regulation for Europe
In fact, however, regulation for medical devices started relatively late, triggered mainly by a major public concern in the s and s regarding the risk of micro-shock from an electrical current via devices connected to patients. During the s and s, demand for stronger regulatory legislation arose from serious effects caused by intrauterine contraceptive devices the Dalkon shield and the Copper-7 device and several brands of tampons.
Beginning in the s, countries with a strong medical device industry4xAmong them Canada, United States, Japan and the European Union.
These countries nowadays account for close to eighty percent of the medical devices market share. World Health Organization. The United States is the largest market for both pharmaceuticals and medical devices, which are estimated to be The European pharmaceutical and medical devices market is the second largest, representing Cunningham, B.
Kelly, C. The medical devices industry is highly fragmented, consisting of small niche markets with only a few products. The highest percentage of these is single-market regulation and innovation in europe medical devices industry in Germany, followed by the United Kingdom.