A Medical Device's intended purpose is not the same as its indication
The understanding and use of the terms “intended purpose” and “indication” differ among Medical Device manufacturers. This inconsistency in interpretation may prove treacherous when the clinical strategy is being planned, and may lead to negative results during the assessment of conformity with the requirements of the applicable directive.
While the term “indication” refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the Medical Device, the term “intended purpose” describes its effect on the human body (e.g. the replacement or removal of a body part, etc.).