NiSV-Anzeige des Betriebes für Anlagen zur Anwendung nichtionisierender Strahlung am Menschen für kosmetische oder sonstige nichtmedizinische Einsatz

Anyone who treats people with non-ionizing radiation for non-medical reasons, e.g. with laser or magnetic field devices, intense light, electrostimulation or ultrasound, must always notify the competent authority in advance

The competent authority must accept the notification of commissioning or operation of existing installations before December 31, 2020.

In addition to the notification, for applications in which the integrity of the epidermis as a protective barrier is violated (laser, high frequency, ultrasound) and for systems for stimulating the central nervous system in humans, proof of the obligation of a licensed physician with appropriate medical training is required.
When using magnetic resonance imaging (MRI) equipment, proof must be submitted that the person using the equipment is a doctor with specialist knowledge in the proper operation of MRI.

For applications in which the integrity of the epidermis as a protective barrier is violated (laser, high frequency, ultrasound) as well as for systems for stimulating the central nervous system in humans, from 31.12.2020 only licensed physicians with appropriate further medical training may carry them out.
As of December 31, 2020, magnetic resonance tomographs (MRI) may only be used under the responsibility of a doctor with specialist knowledge in the proper operation of MRI.

There are no costs.

• When purchasing systems from December 31, 2020, the notification must be submitted no later than two weeks before commissioning.
• The operator of the system must provide information on the identity of the operator or company, the address of the operating site and information on the identification of the system(s) or combination device and the type of application(s).
• The person(s) using each system must be named.
• From 31.12.2022, the obligation to provide evidence of the specialist knowledge of the person(s) using the equipment applies. This evidence must then be attached to the notification.

When purchasing systems from December 31, 2020, the notification must be submitted at least two weeks before commissioning.

Compliance with the general requirements for the operation of the system(s) and the documentation obligations.

If the notification is omitted or incorrect information is provided in the notification, administrative offense proceedings may be initiated.

• Notification of the operation of facilities for the application of non-ionizing radiation to humans for cosmetic or other non-medical purposes Acceptance
• Anyone who treats people with non-ionizing radiation for non-medical reasons, e.g. with laser or magnetic field devices, intense light, electrostimulation or ultrasound, must notify the competent authority in advance.
• The operator of the system must provide information on the identity of the operator or company, the address of the operating site and information on the identification of the system(s) or combination device(s) and the type of application(s).
• The notification must be made in writing.
• In addition to the notification, proof of the obligation of a licensed physician with appropriate medical training is required for certain applications.
• When using magnetic resonance tomographs, proof must be submitted that the person using the equipment is a doctor with specialist knowledge in the proper operation of MRI.
• The notification must be submitted at least two weeks before commissioning.
• Responsible: Thuringian State Office for Consumer Protection (TLV)

Please contact the Thuringian State Office for Consumer Protection (TLV), Department of Technical Consumer Protection, Market Surveillance in Suhl.

• The application can be submitted informally.
• Electronic submission of documents is possible.