Introduction - Medical Device Design: Innovation from Concept to Market - page 7

things taken from the human body, and not necessarily in contact with said body? Once again
it's covered:
(c) “device used for in vitro diagnosis” means any device which is a reagent, reagent
product, kit, instrument, equipment or system, whether used alone or in combination,
intended by the manufacturer to be used in vitro for the examination of samples derived
from the human body with a view to providing information on the physiological state, state
of health or disease, or congenital abnormality thereof; ( EC, 1993 )
No escape there either - this is a medical device too. Once again the wording is pretty clear -
and not worth arguing over. The perennial question comes from the large “made for the patient”
market. Some see this as an escape clause or a loophole; it is not.
(d) “custom-made device” means any device specifically made in accordance with a duly
qualified medical practitioner's written prescription which gives, under his responsibility,
specific design characteristics and is intended for the sole use of a particular patient;
( EC, 1993 )
What it does do is allow for custom-made devices to exist without the premarket assessments
required for mainstream devices. Many custom devices could not exist without this definition;
it does not mean that the design rigor is any less stringent. It definitely does not mean the
medical practitioner takes the blame for any problems - they are not designers or engineers;
you still carry the can for any design issues.
The next definitions relate to the power source, or higher risk functions:
“active medical device” means any medical device relying for its functioning on a source
of electrical energy or any source of power other than that directly generated by the human
body or gravity; ( EC, 1990 )
“active implantable medical device” means any active medical device which is intended
to be totally or partially introduced, surgically or medically, into the human body or by
medical intervention into a natural orifice, and which is intended to remain after the
procedure; ( EC, 1990 )
Once again these are very clear. I hope you noticed that it is the distilling of the legal wording
into small chunks that has made these definitions understandable. Seeing them on a single
sheet is daunting. Throughout this topic I aim to present the important issues in this manner.
The lesson, however, is that no matter which of the above definitions your device falls into
then do the right things and follow a structured procedure. It is important to note that they are
all medical devices and are all governed, ultimately, by that definition.
However, as technology advances some products and processes become more dangerous than
they were before. So there are two issues we designers have to consider: the first is that we