Medical Devices

Advertising of medical devices

Advertising of medical devices is regulated by Articles 59 and 60 of the Medical Devices Act (Official Gazette, no. 76/13).

Advertising of medical devices within the meaning of the Act means any activity designed to promote the prescription, sale or consumption of a medical device, in any written or oral form, using picture and sound, in electronic, digital or other form.

It is prohibited to advertise any medical device which does not meet the requirements laid down by the Act, with the exception of medical devices intended to be used in exhibitions, demonstrations, trade fairs etc. Such devices must be provided a visible sign clearly indicating that they cannot be marketed or put into service.

Misleading advertising of medical devices is prohibited.

Medical devices intended for use exclusively by healthcare practitioners may be advertised but the advertising in such a case must be targeted exclusively to healthcare

Advertising of medical devices must ban any information which:

  • gives the impression that a medical device can guarantee recovery from the illness and that the health of the subject can be enhanced exclusively by using the advertised medical device, whereas the objective judgement must be furnished by evidence,
  • suggests that the health of the subject could be affected by not using the medical device that has been advertised,
  • encourage the patients to abandon the generally accepted treatment procedures,
  • is directed exclusively or principally at children,
  • confuse by the use of scientific terms unknown to the general public for common health conditions,
  • refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the use of the medical device,
  • suggests that the safety of the medical device is due to the fact that it is natural,
  • could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis,
  • refers, in improper, alarming or misleading terms, to claims of recovery,
  • refers, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease,
  • assaults human dignity.