The Ministry of Health has published a new informational note regarding the marketing of injectable fillers, both resorbable and non-resorbable, intended for filling and reconstructive purposes. The clarification arises following reports concerning the sale of these products through online channels, pharmacies, and para-pharmacies, with the possibility of purchase also by individuals who do not possess the necessary professional qualifications.
In the document, it is reiterated that injectable fillers fall within the scope of Regulation (EU) 2017/745 on medical devices (MDR), as devices intended by the manufacturer to be used on patients exclusively by qualified healthcare professionals. The intended purpose indicated by the manufacturer is a central element of the European regulatory framework: under article 5 of the MDR, a device may be placed on the market and put into service only if it complies with the applicable safety and performance requirements and is used in accordance with its intended purpose.
The Ministry of Health further emphasises that fillers are injectable devices requiring a medical procedure and are not intended for self-administration. Consequently, any sales modality that makes such products directly accessible to non-qualified individuals is considered to be in conflict with the principle of use in accordance with the intended purpose set out in the European Regulation.
Particular attention is also given to the obligations of distributors. Referring to article 14 of Regulation (EU) 2017/745, the note highlights that pharmacies, para-pharmacies, distributors, and e-commerce operators are required to verify that the supply of devices complies with the conditions established by the manufacturer, including those relating to intended users. In this context, operators within the supply chain must therefore adopt appropriate measures to ensure that the sale of fillers is restricted exclusively to healthcare professionals possessing the required competencies.
The note also refers to the previous communication issued by the Italian Medicines Agency (AIFA) on 8 September 2023, which had already highlighted the public health risks associated with the improper use of fillers and reiterated the need for aesthetic medicine treatments to be performed exclusively by licensed physicians with specific professional expertise.
This clarification from the Ministry represents a further sign of regulatory attention towards the medical aesthetics device sector and confirms the growing focus on compliance with intended use, proper device distribution, and the responsibilities of economic operators involved in the supply chain.
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