Scope of application |
The directive applies to medical devices and their accessories. Medical device means any instrument, apparatus, plant, substance or other product, used alone or in combination (including the computer software used for correct functioning) and intended by the manufacturer to be used in humans for the purpose of diagnosis, prevention , control, therapy or alleviation of a disease; to diagnose, monitor, treat, alleviate or compensate for an injury or handicap; study, replacement or modification of anatomy or of a physiological process; intervention on conception, which product does not exert the main action, in or on the human body, for which it is intended, by pharmacological or immunological means or by metabolic process but whose function can be assisted by such means.
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