NiSV Obligations for Cosmetic Studios: The Complete Overview 2026
Professional qualification, registration requirement, documentation, and fines — what studio operators need to know now
What does the NiSV regulate?
The Regulation on Protection Against Harmful Effects of Non-Ionizing Radiation in Applications on Humans (NiSV) has been fully in force since 31 December 2020. It regulates the use of devices that employ non-ionizing radiation or electromagnetic fields for cosmetic or other non-medical purposes on humans.
The NiSV primarily affects cosmetic studios, nail salons, tattoo studios, hair salons, and wellness facilities that work with laser, IPL, high-frequency, ultrasound, or EMS devices. The aim is to protect consumers from health damage caused by improper application.
Which devices fall under the NiSV?
The NiSV distinguishes between different technologies and assigns them to different paragraphs:
| Technology | NiSV paragraph | Typical applications |
|---|---|---|
| Laser | §5 (laser and intense light sources) | Hair removal, tattoo removal, skin rejuvenation |
| IPL (Intense Pulsed Light) | §5 (laser and intense light sources) | Hair removal, pigment treatment, acne |
| High-frequency / RF | §6 (high-frequency devices) | Skin tightening, fat reduction, RF lifting |
| Ultrasound (above threshold values) | §9 (ultrasound) | Cavitation, HIFU, phonophoresis |
| Low-frequency / EMS | §7 (nerve and muscle stimulation) | Muscle stimulation, EMS |
| Magnetic field | §7 (magnetic field stimulation) | Magnetic field therapy |
| Direct current (above 0.5 mA) | §7 (nerve and muscle stimulation) | Iontophoresis, galvanic treatment |
Not covered by the NiSV: Pure LED masks (without laser), mechanical microdermabrasion, steam baths, wax heaters, and UV nail lamps. However, these devices must still be tested according to DGUV V3.
Professional qualification: Mandatory since end of 2022
Since 31 December 2022, NiSV devices may only be operated by persons with the corresponding professional qualification certificate (Fachkundenachweis). The qualification must be obtained through a certified training course. Transitional provisions under §13 NiSV allow simplified evidence until 31 December 2025.
Modules and content
- ✓ Fundamentals (Module GK): Physical principles, interaction with tissue, risks — mandatory for all
- ✓ Optical radiation (Module OS): For laser and IPL — includes skin type determination, contraindications, dosimetry
- ✓ High-frequency (Module HF): For RF devices — mechanisms of action, safety limits
- ✓ Ultrasound (Module US): For ultrasound devices above threshold values
- ✓ EMF (Module EMF): For EMS, magnetic field, and direct current
Costs and validity
The costs for the professional qualification certificate typically range between 1,500 EUR and 2,500 EUR per module, depending on the provider and scope. The qualification certificate is valid for 5 years and must then be renewed through a refresher course.
Registration requirement with the authority
Anyone who commercially operates an NiSV device must register this with the responsible state authority at least two weeks before commissioning (§3 para. 2 NiSV). The registration must include:
- ✓ Name and address of the operator
- ✓ Location of the installation
- ✓ Type and model of the device
- ✓ Proof of professional qualification of the applying person(s)
- ✓ Information on the intended use
In Baden-Württemberg, the respective regional council (Regierungspräsidium) is responsible. For the Pforzheim, Karlsruhe, and Stuttgart area, this is the RP Karlsruhe or RP Stuttgart.
Documentation obligations under §3 para. 1 NiSV
The NiSV requires comprehensive documentation. The following records must be maintained for each device:
- ✓ Device log: Type, manufacturer, serial number, commissioning date, maintenance history
- ✓ Test reports: Proof of regular technical testing
- ✓ Application documentation: Record of each individual application (client, parameters, result)
- ✓ Professional qualification certificate: Current certificate of the applying person
- ✓ Informed consent documentation: Proof that the client was informed about risks
- ✓ Consent: Written consent of the client
Physician reservation: These applications may only be performed by doctors
For certain applications with increased risk, a physician reservation applies — these may only be performed by licensed physicians:
- ✓ Ablative laser treatments (e.g. CO2 laser for skin resurfacing)
- ✓ Tattoo removal with laser or IPL
- ✓ Treatment of pigment disorders with laser/IPL (except hair removal)
- ✓ Applications on children and adolescents under 18 years
- ✓ Operative and invasive procedures with NiSV devices
Note: The physician reservation applies even if the device could technically be operated by a cosmetician. The decisive factor is the type of application, not the device.
Sanctions: Fines and further consequences
Violations of the NiSV are punished as administrative offenses under §8 NiSG:
- ✓ Fines up to 50,000 EUR per violation — e.g. missing qualification, missing registration, missing documentation
- ✓ Prohibition of operation: The authority can prohibit the operation of individual devices or the entire studio
- ✓ Device confiscation: In case of serious violations, devices can be confiscated
- ✓ Competition law warning: Competitors can issue warnings for NiSV violations as unfair competition — costs: 1,500–5,000 EUR per warning
- ✓ Criminal law: In case of bodily harm due to improper application, criminal consequences may follow
The state authorities in Baden-Württemberg have been conducting systematic inspections since 2024. Cosmetic studios in the Pforzheim, Karlsruhe, and Stuttgart area should keep their documentation current and complete.
The technical side: Electrical testing obligation for NiSV devices
In addition to the NiSV-specific requirements, all NiSV devices must also be electrically safe. This means:
- ✓ DGUV V3 testing: Regular electrical safety testing of all equipment
- ✓ DIN EN 62353: For devices classified as medical devices
- ✓ §3 para. 1 NiSV: Functionality must be ensured before each application
- ✓ Maintenance per manufacturer specifications: Regular maintenance is a prerequisite for safe operation
Elektrotechnik Driller tests your NiSV devices
We test the electrical safety of your NiSV devices according to DGUV V3 and DIN EN 62353. You receive a standards-compliant test report that you can use as proof of technical testing in your NiSV documentation. Alexander Driller is TÜV Süd certified and serves the Pforzheim, Karlsruhe, and Stuttgart area.
Checklist: NiSV obligations at a glance
- ✓ Professional qualification certificate for all applying persons available and valid?
- ✓ Registration with the responsible authority completed?
- ✓ Device log maintained for each NiSV device?
- ✓ Test reports for electrical safety testing up to date?
- ✓ Application documentation complete?
- ✓ Client informed consent documented?
- ✓ Physician reservation observed for relevant applications?
- ✓ Maintenance per manufacturer specifications performed?
Have your NiSV devices tested now
Protect yourself — with a professional electrical safety test of your NiSV devices: