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This directive applies to many medical products. According to the MDD,
Article 1.2a, a definition of a medical device is: "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 any
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..."
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