NISV LEGISLATION 2020/21

NON-IONIZING RADIATION PROTECTION ORDINANCE (NISV)

PROHIBITIONS ON THE USE OF CRYOLIPOLYSIS, TATTOO LASER REMOVAL & HIFU FOR COSMETIC STUDIOS

On March 25, 2020, the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU), based on the NiSV, in cooperation with the Federal Office for Radiation Protection (BfS), in coordination with the federal states and taking into account comments from representatives of tradesmen, industry and associations, published the requirements for the acquisition of expertise for applications of non-ionizing radiation sources to humans (expert guideline).

Many of these non-ionizing radiation applications on humans currently take place in the cosmetic, non-medical sector in particular. These include ablative laser & light applications, application of lasers to vascular changes and to pigmented skin changes. This mainly concerns IPL devices, SHR devices, IPL-SHR devices, SHR lasers/SHR diode lasers for permanent hair removal. Also affected by the legislation are tattoo removal (tattoo laser removal) and permanent makeup, and all the aforementioned technologies that violate the epidermal integrity of the skin. Also, treatments for the reduction of fatty tissue (cryolipolysis), high-intensity focused ultrasound (HIFU), and ultrasound cavitation are henceforth reserved only for physicians or, in isolated cases, their delegation.

The reason for the adoption of the NISV is that all the mentioned treatments & technologies were allowed to be performed by any person – even without qualification – so far, despite existing health risks. Thus, in the future, consumers shall be protected in their health by the NISV legislation.

The new regulation includes general requirements for the operation of facilities or their operators who work with non-ionizing radiation and use it on humans – for cosmetic or other non-medical purposes. The operator of such facilities must always ensure that they are operated in compliance with the regulations by, among other things, ensuring that the persons using them have been properly instructed in their work.

In addition, the plant operator also assumes responsibility for any maintenance measures of the equipment, has duties to inform about possible (health) side effects & risks of the application and must take appropriate preventive measures for these, so that the protection of the consumer is guaranteed.

The NISV ordinance also specifies qualification requirements for those persons who work with non-ionizing radiation applications – the so-called technical qualification. The NonIonizing Radiation Protection Ordinance specifies the contents of specialist knowledge (theory and practice) and the acquisition of specialist knowledge (training at accredited institutions or notified bodies). Depending on the application, it may be possible that this is henceforth reserved only for licensed physicians and/or their delegation.

FREQUENTLY ASKED QUESTIONS ABOUT NISV

The NiSV applies to applications on humans with

  • Laser devices and intense light sources, including IPL devices, SHR devices, IPL-SHR devices, SHR diode lasers/SHR lasers for permanent hair removal or tattoo lasers for tattoo removal,
  • Radiofrequency devices, including those for wrinkle or fat reduction (e.g., HIFU devices),
  • EMS devices, e.g. for muscle building in fitness facilities and for magnetic field stimulation,
  • equipment for nerve stimulation, e.g. for performance enhancement, and
  • devices with ultrasound effect, e.g. for fat reduction (e.g. lipolaser).

provided that these applications are carried out for cosmetic-aesthetic or other non-medical purposes – and in the commercial sector. If treatments are performed for medical purposes, they do not fall under the regulations of the NiSV.

The NISV will come into force on 31.12.2020. From this date onwards, certain applications will only be subject to the reservation of physicians.

The required certificate of competence must be provided by 31.12.21.

Yes, as of 12/31/20 there is a notification requirement for non-ionizing radiation applications. You must report this to the responsible authority 2 weeks before the intended start of operation.

Yes, even as a non-medical professional, devices for permanent hair removal may continue to be operated against the background of the NISV. The prerequisite is that the required certificate of competence has been provided by 31.12.21.

  • Tattoo laser removal as well as permanent make up removal via laser;
  • Applications to vascular changes;
  • Applications of pigmented skin changes;
  • Applications of ablative laser devices;
  • Applications involving injury to the epidermis as a protective barrier; and
  • Optical radiation applications that affect not only the skin but also the tissue (e.g. fat tissue reduction).

Please contact the Federal Office for the Environment, Nature Conservation and Nuclear Safety (BMU) directly for more information. The BMU can inform you of accredited bodies that are officially legitimized to offer expert training.

The term “physician’s proviso” refers to the fact that an application may now only be carried out by a licensed physician. However, in the course of the NISV there is the possibility that the physician can make use of his right of delegation. This means that the physician can delegate the execution of the application to a qualified person (certificate of competence). In this case, however, there is a medical supervision obligation, so that the person of the physician can be called in at any time at short notice for treatment. For this, spatial proximity is a prerequisite.

(Quelle: https://www.bmu.de/gesetz/nisv-bekanntmachung-der-anforderungen-an-den-erwerb-der-fachkunde-fuer-anwendungen-nichtionisierend/)

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