Medical technology extends and improves life. It alleviates pain, injury and handicap. Its role in healthcare is essential. Some 500.000 technologies (10.000 generic groups) are available today. These are “medical devices”, according to the definition of the EU Medical Devices Directive (93/42/EEC), and more specifically:
“any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.” (Directive 93/42/EEC)
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