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Italy: COVID-19 – The Ministry of Health prohibits the marketing and orders the withdrawal of medical devices irregularly placed on the Italian market

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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.

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Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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