The NiSV comes into force on 31.12.2020.
The provisions regarding expertise will go into effect on 12/31/2021.
The physician proviso begins on 12/31/2020.
Device notifications as of 31.3.2021

Extremely low limit values mean that practically all devices that conduct electric current onto or into the skin fall under the regulation. The device examples are not exhaustive and are provided only to help you understand the subdivision of the various technologies. Depending on the manufacturer, devices may operate in multiple frequency ranges and technologies.

The regulation does not apply to medical device applications.
The regulation does not apply to private (non-commercial) purposes.
The regulation does not apply to the operation of UV irradiation equipment.

LASER APPLICATIONS FOR:
- ablative laser applications
- violation of the integrity of the epidermis as a protective barrier
- treatment of vascular changes
- pigmented skin changes
- removal of tattoos or permanent make-up
- fatty tissue reduction.

HIGH FREQUENCY APPLICATIONS FOR:
- violation of the integrity of the epidermis as a protective barrier
- thermal adipose tissue reduction
- treatment of vascular lesions
- pigmented skin lesions

LOW FREQUENCY, EQUIVALENT CURRENT AND MAGNETIC FIELD APPLICATIONS FOR:
- stimulation of the central nervous system in humans

ULTRASONIC APPLICATIONS FOR:
- focused ultrasound when the integrity of the epidermis as a protective barrier is violated
- targeted thermal tissue coagulation
- adipose tissue reduction

MAGNETRESONANCE APPLICATIONS:
- all

The physician's proviso begins on 31.12.2020.

• Laser/IPL/SHR/light therapy devices
• High frequency devices
• Ultrasound devices
• Magnetic field devices

Successful participation in a training course with the learning content of the module "Basics of the skin and its appendages" is not required if a person:

1. has successfully completed a state-certified vocational training course to become a cosmetician,
2. has successfully completed an educational course as a state-certified cosmetician/state-certified beautician,
3. has successfully completed the master craftsman's examination in the cosmetics trade,
4. has at least 5 years of professional experience in the cosmetics industry.

The specialist knowledge must be demonstrated by 31.12.2021 at the latest.

There is legal certainty only for regulated NiSV specialist training courses that are conducted in the accredited DAkkS procedure. This means that the learner receives a personal certification according to ISO 17024 at the end of a passed examination. Currently, no NiSV advanced training courses supervised by an accredited certification body are offered.

Nonetheless, unregulated NiSV technical knowledge courses are already being offered. Affected parties should be aware that courses in the unregulated environment require a costly individual examination by the enforcement agency. The additional costs of the compliance examination must be borne by the applicant.

German states have reported different conditions for recognizing NiSV expertise, according to a DEGEUK survey. Some states only recognize ISO 17024 certified individuals, while others also allow verification of compliance with the NiSV Expertise Directive via an individual examination. The different recognition regulations of the enforcement authorities of the countries can be read here:

https://degeuk.org/erwerb-der-nisv-fachkunde/

This learning module is mandatory for all device applications (except EMS applications). The exceptions are described under "What is recognized by my training/because of my experience?" The learning module is a minimum of 80x45 minutes.

1. anatomy expertise module "basics of the skin and its appendages"
2. assessment of the skin
3. physiology of the skin and its appendages
4. overview of equipment for the use of non-ionizing radiation
5. knowledge of the effects of radiation
6. education of persons
7. exercises
8. practical course
9. examination

This learning module is mandatory for the application of lasers/IPL/SHR and other intense light sources. The learning module is at least 120x45 minutes.

1. legal basics
2. anatomy and physiology of the skin and its appendages
3. physical basics of coherent and incoherent radiation
4. biological effects of optical radiation
5. risks
6. treatment parameters and device settings
7. basics of device technology for the use of optical radiation
8. contraindications, risks and side effects
9. protective regulations and measures
10. combination devices
11. application planning, education of persons and documentation
12. exercises
13. independent performance of various applications under specialist supervision
14. examination

This learning module is mandatory for the use of ultrasound equipment. The learning module is at least 40x45 minutes.

1. legal basics
2. anatomy and physiology of the skin and its appendages
3. physical basics of ultrasound
4. biological effects of ultrasound
5. risks
6. treatment parameters and device settings
7. basics of equipment technology for the use of ultrasound
8. contraindications, risks and side effects
9. protective regulations and measures
10. combination devices
11. application planning, education of persons and documentation
12. exercises
13. independent performance of various applications under medical supervision
14. examination

This learning module is mandatory for the application of high frequency devices. The learning module is at least 40x45 minutes.

1. legal basics
2. anatomy and physiology
3. physical basics about high-frequency electromagnetic fields
4. biological effects of radiofrequency electromagnetic fields
5. treatment parameters and device settings
6. basic device technology for the use of electromagnetic fields
7. contraindications, risks and side effects
8. protective regulations and measures
9. combination devices
10. application planning, education of persons and documentation
11. exercises
12. independent performance of various applications under specialist supervision
13. examination

The prerequisite for participation in this module is proof of a license as an exercise instructor, at least a C license as a trainer or comparable training.

The learning module is at least 24x45 minutes.

1. legal basics
2. anatomy and physiology of nerve and muscle stimulation
3. physical basics of electric, magnetic and electromagnetic fields
4. biological effects of electric, magnetic and electromagnetic fields
5. treatment parameters and device settings
6. basic device technology for the use of electromagnetic fields
7. contraindications, risks and side effects
8. protective regulations and measures
9. application planning, education of persons and documentation
10. exercises
11. independent execution of different applications under medical supervision
12. examination

The license levels are standardized in the European Union, even if the required hours (modules) vary somewhat in some cases. The standardization makes it possible to instruct training in Germany even with the equivalent European licenses.

In order to meet the many challenges of training and to expand their own knowledge and skills, most coaches enter the training "Trainer C-Leistungssport" in their sport. To do this, they register for a course at the state association of their professional association, which usually conducts the training at the 1st license level (C). The courses are offered in different modules - often spread over 8-10 weekends or as weekly blocks - and usually last about half a year.

After 120 learning units and learning success controls, the basics for the trainer activity in the beginner and advanced area are laid and the trainers receive the "C license competitive sports" issued by the state professional association. For most coaches, this qualification at the first license level and the regular further training courses are sufficient for their work in the club.

Notification of existing equipment already in operation as of December 31, 2020: 03/31/2021.
The notification must state the name or company name of the operator as well as the address of the operating site and the details for identifying the respective equipment. The notification must be accompanied by proof that the persons using the equipment have the required expertise (applicable from 31.12.2021).

If equipment is acquired after 31.12.2020, the operator of a device must notify the competent authority of the operation of the equipment at least two weeks before commissioning. The competent authority varies by federal state and can be viewed via the following link:

https://www.bmu.de/themen/atomenergie-strahlenschutz/strahlenschutz/uv-strahlung/vollzug-der-nisv/

Written evidence must be provided that the operator and user obligations have been fulfilled.

Reporting forms are available in the member portal. https://portal.degeuk.org/index.php Operator obligations

• Proof of installation
• Proof of instruction
• Equipment documentation

User obligations

• Device selection
• Functionality
• Maintenance intervals
• Reporting form for devices

CUSTOMER EDUCATION

• Application, effect
• Risks, side effects
• Explain alternatives and their risks
• Proof of customer education (educational discussion)
• Documentation of application parameters
• Minimize risks
• Specialist clarification if required
• Protect third parties

If the device is a medical device, the MPBetreibVO must be observed.
https://www.gesetze-im-internet.de/mpbetreibv/__3.html

The required forms, such as:

• Equipment logbook
• Notification of device operation
• Customer information
• Documentation of the application
• and many more

can be found in the member portal.
https://portal.degeuk.org/index.php

Anyone who violates the NiSV intentionally or negligently commits an administrative offense.

The following violations are punishable:

• Whoever fails to ensure that a system is installed in accordance with the manufacturer's specifications.
• who does not ensure that instruction is given.
• who does not ensure that a person is advised and educated.
• who does not ensure that a person is protected.
• who does not ensure that documentation is made.
• who does not make a report, does not make a report correctly, does not make a report completely, or does not make a report in a timely manner.
• who does not ensure that a named person has the expertise.
• who performs an unauthorized application.
• who uses a magnetic resonance tomograph.
• who exposes a fetus when using ultrasound equipment.