Which devices are covered
The NiSV applies to commercial, non-medical use on humans. It covers lasers and intense light sources (IPL), high-frequency and radiofrequency devices, electrical muscle and nerve stimulation, magnetic field stimulation and ultrasound, among others. It does not apply to medical treatments.
Duty to notify
Anyone operating such a device commercially must notify the competent authority no later than two weeks before starting operation. Proof of expertise is submitted with the notification. Depending on the federal state, the trade supervisory office or occupational safety office is usually responsible.
Certified expertise since 2026
Operators need expertise according to Annex 3 of the NiSV, separately for each technology. Since early 2026 it is normally proven by a certificate from an accredited conformity assessment body after passing an exam. The transitional rule accepting simple training records expired at the end of 2025. A refresher is required every five years.
Physician reservation
Certain treatments may only be carried out by licensed physicians with relevant training. These include removing tattoos and permanent make-up, treating vascular and pigmented lesions, ablative laser treatments and treatments that penetrate the epidermis. They also include optical methods and radiofrequency for fat reduction and ultrasound for targeted thermal coagulation or fat reduction, which covers HIFU.
Checklist before you buy
- Is the device covered by the NiSV, and under which technology?
- Is the planned treatment open or reserved for physicians?
- Does the team hold a valid expertise certificate?
- Is notification planned two weeks before operation?
- Are safety goggles and instruction organised?
Frequently asked questions
May a beautician remove hair with a laser in Germany?
Yes. Hair removal with laser or IPL is not reserved for physicians. You do need certified expertise and must notify the authority.
Where do I obtain NiSV expertise?
From training providers that teach according to Annex 3 of the NiSV. The exam and certificate are handled by an accredited conformity assessment body.
Does the NiSV apply to cryolipolysis?
Cold-based methods are not explicitly named in the NiSV. If in doubt, clarify the classification of your specific device with the competent authority.
Sources
- Bundesumweltministerium: Grundsätzliche Fragen zur NiSV
- NiSV, Verordnungstext (gesetze-im-internet.de)
- Gewerbeaufsicht Bayern: Merkblatt NiSV
This guide is for orientation only and is not legal advice. The current text of the regulation applies. If in doubt, please ask the competent authority.