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In brief

On 19 January, the Court of Justice of the European Union (CJEU) specified that Art. 2(2) of Directive 2001/83/EC, pursuant to which, in case of doubt on the classification of a product as a medicine or a medical device, the provisions on medicinal products shall apply, covers both “medicinal products by function” (i.e., substances exerting pharmacological, immunological or metabolic action) and “medicinal products by presentation” (i.e., substances presented as having properties for treating or preventing disease).

Key takeaways

Moreover, with reference to the distinction between a medicinal product and a medical device, the CJEU clarified that where the principal mode of action of a product is not scientifically established, that product cannot meet the definition of medical device nor of medicinal product by function and that, in such a case, it is for the national courts to assess, on a case-by-case basis, whether the conditions relating to the definition of “medicinal product by presentation” are satisfied.


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.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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