Service Finder

back

NiSV notification of the establishment for facilities for the application of non-ionizing radiation to humans for cosmetic or other non-medical use

Service Description

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

Process flow

  • 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.

Who should I contact?

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

Requirements

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.

Which documents are required?

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.

What are the fees?

There are no costs.

What deadlines do I have to pay attention to?

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

Legal basis

Appeal

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

What else should I know?

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.

Comments

The following information is available:
Observe the specifications on 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.

Further Information

Author

Thuringian State Office for Consumer Protection (TLV)

The text was automatically translated based on the German content.

Technically approved by

Thuringian Ministry of Labor, Social Affairs, Health, Women and Family (TMASGFF)

Professionally released on

19.06.2024

Source: Zuständigkeitsfinder Thüringen (Linie6Plus)

No competent authority found

Please enter your location.