Section 1: General provisions

Advertising to the public for an in vitro diagnostic medical device:

1° Is designed in such a way that the advertising nature of the message is obvious and the product is clearly identified as an in vitro diagnostic medical device;

2° Specifies the date on which it was drawn up or the date of the last modification and includes at least the following information:

a) The name or trade reference of the in vitro diagnostic medical device;

b) The purpose assigned to the in vitro diagnostic medical device by its manufacturer and for which it is advertised;

c) The name of the manufacturer of the in vitro diagnostic medical device or its authorised representative;

d) Information essential for the proper use of the in vitro diagnostic medical device;

e) an express invitation to read carefully the instructions given in the package leaflet accompanying the in vitro diagnostic medical device or on the labelling supplied to the end user;

f) depending on the degree of risk that failure of the in vitro diagnostic medical device is likely to present to health, a message of caution and a reference to the advice of a doctor, pharmacist, medical biologist or any other professional competent in respect of the nature of the in vitro diagnostic medical device;

g) the words: "this in vitro diagnostic medical device is a regulated health product which, under these regulations, bears the CE mark";

h) Where applicable, the internal reference number;

3° Does not include any statement to the effect that the in vitro diagnostic medical device is reimbursed, in whole or in part, by compulsory health insurance schemes or by a supplementary scheme;

4° Does not include any element which :

a) Makes medical consultation or surgical intervention appear superfluous, in particular by offering diagnosis by correspondence;

b) Suggests that a normal state of health can be improved by using the in vitro diagnostic medical device;

c) Suggests that a normal state of health can be affected if the in vitro diagnostic medical device is not used;

d) Is aimed exclusively or principally at children;

e) Refers to a recommendation made by scientists, health professionals or persons who, although not scientists or health professionals, are known to encourage the use of in vitro diagnostic medical devices;

f) Could lead, through a detailed description of symptoms, to a false self-diagnosis;

g) Would use in an abusive, frightening or misleading manner visual representations of alterations to the human body due to illness, injury or disability;

h) Refer to certificates of cure;

i) Insist on the fact that the in vitro diagnostic medical device has been certified;

j) Include offers of premiums, objects or products of any kind or direct or indirect material advantages of any kind whatsoever.