Advertising. Medical devices and IVDs
Does your company manufacture or is it responsible for the marketing of medical devices or IVDs and do they wish to advertise their products to the public?
Well, this article could be useful. First of all, the first thing to know is that to advertise a MD or an IVD in Italy, it is mandatory to apply for an authorisation to the Italian Ministry of Health that, via a panel of experts, assesses the advertisements intended for the public.
The rationale related to this authorisation is clear: the protection of consumers’ health.
Who regulates medical device advertising?
The rules governing medical device advertising appear to be quite recent, as this is regulated by art. 21 of Leg.Dec. 46/97 (that, as confirmed by the Ministry of Health, remains in force in spite of the application of Regulation (EU) of 2017/745), but it was the Royal Decree no. 1265 of 1934 that actually started to define limits to the advertising of health products to the public.
This authorisation is to be applied for all types of medical devices and IVD with the exceptions listed below.
The advertising regulation, in fact, does not apply in case of medical device accessories such as frames for glasses, or in case of promotion of medical devices via the sale of multiple packs or for corporate communication.
On the other hand, products that cannot be advertised include for instance customised medical devices, MDs that can be sold to the public upon medical prescription and MDs mandatorily used in the presence of a physician.
When an advertisement is approved, the company that applied for the advertising authorisation is obliged to report also the authorisation date in the text of the advertisement.
Advertising media
As far as the communication media, as we know, nowadays there are many, especially tanks to the development of new technology.
However, the concept remains the same: all advertising intended for a non professional public are to be authorised by the Ministry.
Because of the wide range of media available, the Ministry has released a guideline appropriately leading the companies wishing to use all media allowed for the advertising of one’s products.
The increased use of the internet and social networks to reach as many consumers as possible has induced the Ministry to publish updated guidelines for e-commerce websites, Youtube, Facebook, Instagram…
For instance, to advertise medical devices and IVDs on the internet, an authorisation needs to be applied from the Ministry; if, however, this advertising is addressed to health professionals no authorisation is required and it will be sufficient for the company to include an appropriate “disclaimer” to warn users that the information contained in that page are only intended for professionals.
Written by: Federica Montozzi
Foto di Bruno /Germany da Pixabay
