Surgical masks and advertising to public
Masks are now part of our daily life. There are several types of masks on the market: surgical masks, single-use fabric or washable masks, whose aim is to provide an adequate barrier through appropriate shape and adherence allowing to cover the area from chin to nose, ensuring at the same time comfort and respiration; FFP2 and FFP3 filtering face masks, offering wider protection to wearers.
Although the function of the various type of masks is similar, i.e. to reduce the virus circulation, their classification is different.
Masks and Regulations
FFP2 and FFP3 masks are a personal protective equipment (PPE), regulated by a specific regulation; surgical masks are medical devices (MDs), regulated by different norms; and fabric masks are common goods to be considered as an hygiene measure to reduce the viral spreading, but not subject to any special regulation. The different reference regulations also determine different obligations, including those regarding advertising.
Surgical masks advertising addressed to consumers would be subject to a preliminary Ministry authorisation. In fact, differently from the other types of product (PPE, common goods), for medical devices it is mandatory to apply for an authorisation of the Ministry of Health for their advertising to the general public.
On this topic, the Section on advertising of the Technical Health Committee of the Ministry of Health has however asked for the opinion of the General Directorate of Medical Devices and Pharmaceutical Services.
Surgical masks were in fact designed as medical device to be used in health environments and intended for specialised health professionals (as also resulting from the description reported in the National Classification of Medical Devices – CND). The norm provides for that advertising of medical devices addressed to health professionals is not subject to authorisation, but it is considered as free. The ratio is in the fact that health professionals have already a suitable culture and knowledge for a correct use of the device.
However, due to the ongoing pandemic, final users of surgical masks are not only health professionals, but also average citizens.
The Ministry has however considered unnecessary to authorise surgical masks advertising, also when addressed to public, as it is the only kind of masks available for which such authorisation would be required. It is also considered that citizens are already adequately informed on the functions of this MD and on the correct procedures for its use and disposal.
Nonetheless, the general principle that advertising should be fair, and should not mislead the consumer on the advertised product, still applies. In particular, the Ministry of Health stressed the fact that public advertising should include indications on the use of face masks in the daily life and in accordance to the information already disseminated by the authorities.
In case of misleading advertising messages, the Ministry of Health can take actions aimed at ensuring the protection of citizens’ health.
Written by: Federica Montozzi
Foto di Jordy_Nijenhuis da Pixabay
