Cosmetic use of non-ionizing radiation; notification of the operation of systems

The operation of commercial facilities that use non-ionizing radiation for cosmetic and other non-medical purposes on humans must be reported to the responsible trade supervisory office.

The Ordinance on Protection against Harmful Effects of Non-ionizing Radiation when Used on Humans (NiSV), for example lasers, intense light, high frequency, electrostimulation, ultrasound, applies to equipment that emits non-ionizing radiation and is used for cosmetic or other non-medical purposes on humans.

Among other things, the operator must ensure that safety precautions are taken to protect the person being treated or third parties from avoidable health risks, that certain documentation and notification obligations are complied with and that maintenance is carried out in accordance with the manufacturer's instructions. The persons using the equipment must also be instructed in its proper use and be able to provide evidence of the necessary specialist knowledge or participation in training courses.

The operator must report the following systems to the responsible trade supervisory office:

• Laser devices and intense light sources, for example for permanent hair removal or tattoo removal,
• High-frequency devices, for example for wrinkle smoothing or fat reduction,
• Systems for electrical nerve and muscle stimulation, for example for muscle building in sports studios and for magnetic field stimulation, for example magnetic field mats,
• Systems for stimulating the central nervous system, for example brain stimulation to improve performance,
• Ultrasound devices, for example ultrasound baby cinema or for fat reduction and
• magnetic resonance tomographs, for example brain examinations in market research.

Persons using the system must have the necessary specialist knowledge.

The notification must include the name or company name of the operator as well as the address of the operating site and details identifying the respective installation.

Notifications for installations that fall under the NiSV and the required certificates of competence must be submitted to the competent trade supervisory office in the respective government district in which the operator of the installation has its business premises.

The operator must notify the competent authority of the operation of the system at least two weeks before commissioning.

The following treatments may only be carried out by licensed physicians with appropriate medical training or further training:

• Removal of tattoos or permanent make-up
• Treatment of vascular changes
• Treatment of pigmented skin changes
• Ablative laser applications
• Treatments that damage the integrity of the epidermis as a protective barrier
• Applications with optical radiation whose effects are not limited to the skin and its appendages, such as fat tissue reduction

• Certificate of competence