Introduction - Medical Device Design: Innovation from Concept to Market - page 6

- 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; ( EC, 1993 )
I would propose that this is pretty clear; if the device is to be used in any clinical
environment, on humans, then it is a medical device. Note it does not say that the device has
to be in a hospital or used by a clinician - it is defined by intended use . Compare this with the
equivalent definition from the USA (taken from the Federal Food, Drug, and Cosmetic Act -
FD&C Act):
The term “device” (except when used in paragraph (n) of this section and in sections
301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article, including any
component, part, or accessory, which is--
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or
any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals,
and which does not achieve its primary intended purposes through chemical action
within or on the body of man or other animals and which is not dependent upon being
metabolized for the achievement of its primary intended purposes. (FDA, 2004)
The only difference between the two is the inclusion of use on any animal in the USA
definition. Note that both clearly distinguish between a device and a pharmacological agent.
Often devices need accessories or additional items for particular functions; these are
covered too:
(b) “accessory” means an article which whilst not being a device is intended specifically
by its manufacturer to be used together with a device to enable it to be used in accordance
with the use of the device intended by the manufacturer of the device; ( EC, 1993 )
Or if your design is to be used with something from definition (a) then it too is a medical
device. Again, this is pretty clear. What about things used in a laboratory for assessment of