medical device – any instrument, apparatus, appliance, 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:
a) diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
b) diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
c) investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
d) providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
active implantable medical device – 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;
in vitro diagnostic medical device – any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
a) concerning a physiological or pathological process or state;
b) concerning congenital physical or mental impairments;
c) concerning the predisposition to a medical condition or a disease;
d) to determine the safety and compatibility with potential recipients;
e) to predict treatment response or reactions;
f) to define or monitoring therapeutic measures.
Depending on risk, medical devices may be classified as Class I (Is, Im), Class IIa, Class IIb and Class III.
Class I is associated with the lowest risk whereas Class III covers the highest risk products.
Class I device manufacturers are responsible for assessment of conformity for CE marking.
Manufacturers of class Is, Im, IIa, IIb and III medical devices must contact a notified body for assessment of medical device conformity with the applicable medical device directive