Chapter 2

CEIS Health Report 2006
Box 1: Identification of the medical devices
Medical devices active implant, understood as “any active medical device destined to
entirely be installed or partially through surgical intervention or physician in the human
body or through medical intervention in a natural orifice and destined to stay you after the
intervention”;
Physician-diagnostic devices in vitro, defined as “any medical device composed by a
reagent, from a reactive product, from a calibrator, from a material of control, from a kit,
from a tool, from an instrument, an equipment or a system, used alone or in combination,
destined by the manufacturer to be employed in vitro for the examination of champions
coming from the human body, I included blood and given fabrics, entirely or mainly to the
purpose to furnish information on a physiological or pathological state, or on a congenital
anomaly or information that allow the determination of the safety and the compatibility
with receiving subject potential, or that they allow the control of the therapeutic measures.
The containers of the champions they are considered physician-diagnostic devices in
vitro. They intends for containers of champions the devices, of the type in a vacuum or
no, specifically destined by the manufacturers to directly receive the champion coming
from the human body and to preserve him/it to the goals of a diagnostic examination in vitro.
The products destined to generic uses of laboratory are not regulating physician-diagnostic
in vitro unless, you give their characteristics, is specifically destined by the examinations
manufacturer diagnostic in vitro”;
Other medical devices, that don’t reenter in the preceding categories, that satisfy the
general definition of the D. Lgs February 24th 1997, n. 46.
rapy or attenuation of any illness; any diagnosis, control, therapy, attenuation or compensation
of a wound or a handicap; of any study, substitution or change of the autonomy or physiological
trial; of any intervention on the conception, without interfering with the conception
action, in the or on the human body, which it is destined to, with pharmacological or immunological
means neither through a metabolic process but whose function can be assisted by
such means”. Inside this general definition and making reference to the D. Law December
14th 1992, n. 507 (according to the European directive 90/385/CE and to the D. Law
November 7th 2000, n. 332 and to the European directive 98/79/CE) we can distinguish three
great families of medical devices: regulating active implanting, devices for medical diagnostic
in vitro and the remaining devices (Box1).
5.3.5 The market of the medical devices
The world market of the medical devices is valued in about € 184 mlds.; the European
market, second only to the American one, and it represents 30% (€ 55,2 mlds.), about
78% of which is held by five States (Germany, France, Italy, Great Britain and Spain)
(table 4 and 5). According to the OECD, in Europe the sanitary expenditure for the medical
devices represents the 6,2% of the total of the sanitary expenditure (5,4% if the 15
countries of the European union are considered) (table 5).
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