On May 11, 2026, the Italian Ministry of Health published a Circular clarifying the distribution and sales modalities of injectable fillers, both resorbable and non-resorbable, intended for professional use.
The communication follows reports submitted to the Directorate-General for Medical Devices and Pharmaceutical Services. The Circular aims to prevent and limit improper use of aesthetic Medical Devices, also considering that these products may be sold through online channels, pharmacies, and para-pharmacies.
MDR and intended use
The Circular recalls that injectable fillers fall within the scope of Regulation (EU) 2017/745 on Medical Devices (MDR). Therefore, fillers may only be placed on the market if they comply with the General Safety and Performance Requirements and only when used in accordance with the intended purpose defined by the manufacturers (Art. 5 MDR).
The Ministry reiterates that injectable fillers are devices intended exclusively for professional use, excluding self-administration. Consequently, their distribution must be organized consistently with this intended purpose, ensuring that injectable fillers do not become freely accessible to the general public.
As a result, any distribution model allowing direct access to fillers by non-qualified individuals is not compliant, as it is not consistent with the principle of intended use under the European Regulation.
Supply chain verification obligations
The communication refers to Article 14 of Regulation (EU) 2017/745, which requires distributors to verify that the device is supplied in compliance with the conditions established by the manufacturer, including those relating to intended users.
Accordingly, as specified in the Circular, pharmacies, para-pharmacies, distributors, and e-commerce operators are required to verify that devices are supplied in compliance with the conditions established by the manufacturer, including those relating to intended users and intended purpose.
Sales must therefore not be structured in a way that makes fillers directly accessible to individuals lacking the necessary professional qualifications.
In practice, this means that distributors must ensure and verify that fillers are not accessible to the unqualified general public.
Reference to AIFA and public health protection
The Circular also refers to the information note issued by the Italian Medicines Agency (AIFA) on September 8, 2023, which had already highlighted the public health risks associated with improper use of fillers and reiterated that aesthetic medicine procedures must be performed exclusively by licensed physicians with specific professional expertise.
The Ministry is therefore acting to strengthen public health protection and prevent non-compliant use of devices requiring specific professional competence.
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