In brief
With an urgent measure adopted on 19 February 2021, the Ministry of Health prohibited the marketing of Model 2 U-Masks as medical devices and ordered their withdrawal from the Italian market.
Comments
As indicated by the Ministry of Health, this decision was based on the absence of sufficient guarantees about the effective suitability of these products to prevent COVID-19 infections due to the lack of a regular conformity assessment, with consequent potential health risks.
In particular, the above-mentioned measure was adopted following a report by the Italian Anti-Adulteration Units (NAS) that Model 2 U-Masks were marketed as medical devices based on a certification issued by an unlicensed laboratory and signed by a person without the required qualifications.