This Directive shall apply to medical devices and their accessories:
(a) Medical device: 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:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
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;
(b) Accessory: an article which whilst not being a device is intended specifically by its manufacturer
to be used together with a device to enable it to be used in accordance with the use of the device intended
by the manufacturer of the device.
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