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Product Regulation & Liability

Italy: Reclassification of groups of certain active products without an intended medical purpose

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In brief

On 1 December 2022, Implementing Regulation EU 2022/2347 on the reclassification of groups of certain active medical devices without an intended medical purpose, as listed in Annex XVI to Regulation EU 2017/745, was published in the Official Journal of the EU.

Key takeaways

The Implementing Regulation introduces an exception to the general rule, according to which active devices that are not included in a particular risk class according to the classification rules fall into Class I, by providing that: (i) high intensity electromagnetic radiation emitting equipment that is intended for the use on the human body for skin treatment is reclassified as Class IIb, unless it is intended for hair removal, only in which case it is reclassified as Class IIa; (ii) equipment intended to be used to reduce, remove or destroy adipose tissue is reclassified as Class IIb; (iii) equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields to modify neuronal activity is reclassified as Class III.

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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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