top of page

Medical Device Definition

'Medical device' means any instrument, apparatus, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

diagnosis, prevention, monitoring, prediction, treatment or alleviation of disease,

- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood & tissue donations. 

(Definition taken from Medical Device Regulation courtesy of Oxford Global Guidance)

bottom of page