Kosmetische Anwendung nichtionisierender Strahlung; Anzeige des Betriebs von Anlagen

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 (e.g. laser, intense light, high frequency, electrostimulation, ultrasound) when used on humans (NiSV) applies to equipment that emits non-ionizing radiation and is used for cosmetic, non-medical purposes on humans.

Among other things, the operator must ensure that protective measures are taken to protect the person being treated or third parties from avoidable health hazards, 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,
• equipment for electrical nerve and muscle stimulation (e.g. for muscle building in sports studios) and for magnetic field stimulation (e.g. 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.

• Certificate of competence

Persons using the system must have the necessary specialist knowledge.

The notification must state the name or company name of the operator as well as the address of the operating site and the details for identifying the respective system.

The systems or laser systems that fall under the NiSV or certificates of competence must be sent to the trade supervisory office responsible for the administrative district.

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

Since December 31, 2020, the following treatments may only be carried out by licensed physicians with appropriate further medical training or advanced 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