Tests on equipment for aesthetician

Electromechanical equipment for the activity of aesthetician | Decree 206 of 15/10/2015

The Legislative Decree 206 of 15/10/2015 defines the families, types and technical characteristics that the equipment used in the aesthetic field must comply with.

Since the boundary between esthetics and esthetics medicine must be well defined, this decree indicates the limits that this equipment must have, so as not to encroach on a therapeutic treatment and therefore not in line with aesthetic purposes.

However, from 26 May 2020, with the introduction of Regulation (EU) 2017/745 MDR, a reclassification will be made for some types of this equipment, as many aesthetic devices will have to follow the same procedures as medical devices to all intents and purposes, even in the absence of a destination for medical use:

Contact lenses or other elements intended to be placed in or on the eye
Products intended to be introduced wholly or partly into the human body by means of invasive surgical instruments for the purpose of anatomical modification or for the fixation of parts of the body with the exception of tattooing and piercing products.
Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
Equipment emitting high level electromagnetic radiation intended for use on the human body, including coherent and inconsistent, monochromatic and broad spectrum sources, such as lasers and high intensity pulsed light equipment for skin photorejuvenation, tattooing or hair removal or other dermal treatment.
Equipment intended for brain stimulation that applies electric currents or magnetic or electromagnetic fields that pass through the skull to modify the neuronal activity of the brain.
Sostanze, associazioni di sostanze o elementi destinati a essere utilizzati per filling facciali o altri filling cutanei o per le mucose attraverso iniezione sottocutanea, sottomucosa o intradermica, eccetto quelli per i tatuaggi.

In order to verify the CE conformity of the devices produced, manufacturers are required to carry out testing activities through bodies authorized by the competent Ministry and notified by the European Community considered to meet the minimum requirements specified in the applicable Directive.