With sentence no. 15742 of January 30, 2025, the Italian Supreme Court (Cassazione) upheld the order issued by the Court of Perugia, which had rejected the request for review filed by a beauty center against the decree validating the seizure of an anti-aging device listed in the national database of medical devices.

Indeed, although Annex XVI of EU Regulation 745/2017 provides a list of product groups without an intended medical purpose, as per Article 1(2)—including machines used in beauty centers, such as devices intended to reduce, remove, or destroy adipose tissue, or devices that emit high-intensity electromagnetic radiation to be used on the human body—the device in question must be used under medical supervision.

This is because the required patient medical history and the nature of the exclusion criteria involve expertise specific to the medical profession. Medical knowledge and tools are needed to assess these elements, and only after such evaluation and the related medical indications can the machine be used. Its operation is therefore to be considered part of a broader service that inherently requires medical skills.

In the absence of medical supervision, the precautionary principle under Article 191 of the Treaty on the Functioning of the European Union would be violated. According to this principle, if a particular policy or action could potentially harm citizens or the environment and there is not yet a scientific consensus on the matter, such policy or action should not be pursued, unless reconsidered once further scientific information becomes available. As a result, the unauthorized use of the device in such circumstances would constitute the criminal offense of unlawful practice of the medical profession.