MEDICAL DEVICE

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:

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.

For further information on MEDICAL DEVICES, see the Medicines and Healthcare Products Regulatory Agency (MHRA) website at: Medical devices regulation and safety

This class is also known by these names:
ContextAlias
pluralMEDICAL DEVICES

ISO 9001 CERTIFICATION EUROPE