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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.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.