medical device
- Guideline or reference source
- ISO11615 IDMP Data elements and structures for the unique identification and exchange of regulated medicinal product information
- ISO11616 IDMP Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
- Definition
- any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and 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 [European Commission Medical Devices Directive 2007/47]
- Narrower Term
- active implantable medical device
- active medical device
- administration device
- finished device
- Related Term
- registration procedure
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