Section 1: General provisions

Advertising to the public for a 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 a medical device;

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

a) The name or commercial reference of the medical device ;

b) The purpose assigned to the medical device by its manufacturer and for which the advertisement is disseminated;

c) The name of the manufacturer of the medical device or his authorised representative;

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

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

f) Depending on the degree of risk posed by the medical device to human health, a message of caution and a reference to the advice of a doctor, pharmacist or any other professional competent in respect of the nature of the medical device;

g) The statement: "This 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 a statement to the effect that the medical device is reimbursed, in whole or in part, by the compulsory health insurance schemes or by a supplementary scheme;

4° Does not include any information that :

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

b) Suggest that the effect of the medical device is assured, that it is without adverse effects, or that it is superior or equal to that of another treatment or medical device;

c) Suggest that a normal state of health can be improved by the use of the medical device;

d) Suggest that a normal state of health may be affected if the medical device is not used;

e) Addressed exclusively or principally to children;

f) Refer to a recommendation from scientists or health professionals;

g) Refer to a recommendation by persons who, although they are neither scientists nor health professionals, may, by virtue of their reputation, encourage the use of medical devices, unless the advertising concerns a class I or II a medical device;

h) equates the medical device with a foodstuff, cosmetic or other consumer product;

i) Suggest that the safety or efficacy of the medical device is due to the fact that it is a natural substance;

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

k) Misuses, frightens or misleads with visual representations of alterations to the human body due to illness, injury or disability;

l) Present the action of the medical device on the human body in an excessive or misleading manner;

m) Refer to certificates of healing;

n) Insist on the fact that the medical device has been certified;

o) Contain offers of premiums, objects or products of any kind or direct or indirect material advantages of any kind, unless the advertising concerns a class I or II a medical device or condoms.