DRM LEGAL is a law firm with an office in Hamburg, Germany. It was founded in 2012 by attorney Dr. Florian Meyer. DRM LEGAL advises start-up and medium size companies (including Amazon FBA Sellers) from Germany and abroad in the fields of unfair competition as well as product law and media law. One focus of our legal work lies on a strategic consultancy in dealing with regulatory issues, health claims, warning letters, administrative complaints, criminal investigations and product crises.

 

Please feel free to contact us! You will find us in the center of Hamburg City.

Experience (excerpt):

• Lawyer at the life science team of U.S. law firm Jones Day
• Legal adviser at a large German trading company
• Representation of one of the largest German medical societies against a therapy provider in a statement dispute in 34 court proceedings
  
• Advising a commercial enterprise on more than 30 product crises and authority complaints
• External data protection officer for a food company
• Advising a supraregional advertising agency on advertising concepts for pharmaceuticals and food
• Representing a provider of dietary supplements in several criminal proceedings
• Accompanied biocidal product launches in 19 EU Member States
• Drafting and negotiation of various contract manufacturing and distribution agreements in the fields of cosmetics, pharmaceuticals and food supplements
• Advising a pet food retailer in trademark applications and defenses and on feed law issues
• Assessment of various websites offering health and consumer products as well as medical practitioners, Beauty salons and other service providers in the health sector
• Advising start-ups on product launches and drafting contracts, in trademark law and on the General Data Protection Regulation

Current Topic: German regulation on protection against non-ionising radiation (NiSV-Verordnung) 

 

In 2018 the German legislator passed the Regulation on the protection against harmful effects from non-ionizing radiation when used on humans (so called NiSV-Regulation) which will enter into force on December 31, 2020. What is this regulation about and what impact does it have on the health sector, in particular the cosmetics and wellness sector? Below we provide you with the essential content of this law.

 

According to the regulation, certain cosmetic or non-medical device applications covered by the NiSV are reserved for licensed doctors. Applications require specialist training or further training. General requirements for the operation of the devices also apply.

 

Scope of the Regulation

 

The regulation applies to the

 

• Operation of systems for the use of non-ionizing radiation in humans and
• That are used for cosmetic or other non-medical purposes or in the context of other economic activities

Non-ionizing radiation includes

 

• electric, magnetic and electromagnetic fields in a frequency range from 0 Hertz to 300 Gigahertz;
• optical radiation in the wavelength range from 100 nanometers to 1 millimeter as well;
•  Ultrasound in the frequency range from 20 kilohertz to 1 gigahertz.

 

The following devices fall within the Regulation:

 

• Intense light sources that emit intense pulsed or unpulsed incoherent optical radiation, the purpose of which is to exert an effect on the target tissue;
• Laser devices that use a laser of classes 1C, 2M, 3R, 3B or 4 according to DIN EN 60825-1: 2015;
• Ultrasound devices that can cause sound intensities of more than 50 milliwatts per cm2 on the eye or more than 100 milliwatts per cm2 on the rest of the body with a mechanical index greater than 0.4 or a thermal index greater than 0.7 that can be used for imaging for non-medical purposes;
•  High-frequency devices that generate high-frequency electromagnetic fields

1. emit in the frequency range from 100 kilohertz to 300 gigahertz, which, when used on humans, can lead to specific absorption rates or power densities that may exceed the basic limit values in Appendix 1 of the NiSV
2.  emit in the frequency range from 100 kilohertz to 10 megahertz, which, when used on humans, can cause internal electric field strengths in the body that exceed the basic limit values of Appendix 1 of the NiSV, or
3. emit in the frequency range from 100 kilohertz to 110 megahertz, which when used in humans can cause contact currents that exceed the reference values in Appendix 1 of the NiSV;

• Low-frequency devices that emit electrical or magnetic fields in the frequency range from 1 hertz to 100 kilohertz or produce currents in the body that, when used on humans, can cause electric field strengths in the body that exceed the basic limit values of Appendix 1 of the NiSV or that can cause contact currents that can exceed reference values of Appendix 1;
• Direct current devices that can produce electrical direct current (contact current) of more than 0.5 milliamperes and current densities of more than 8 milliamperes per square meter in the body;
• Magnetic field devices that generate static magnetic fields of more than 400 millitesla, including magnetic resonance tomographs.

 Not within the scope of the NiSV e.g.: Cryolipolysis, Microneedling, Microdermabrasion

 

The following treatments are only allowed for doctors and from Dec. 31, 2020 forbidden for aestheticians and alternative medical practitioners

 

Intense light sources Laser devices Ultrasound devices High-frequency devices	Applications in which the integrity of the epidermis as a protective barrier is violated Adipose tissue reduction
Intense light sources Laser devices High-frequency devices	Treatment of vascular changes (e.g. treatment of varicose veins) Treatment of pigmented skin changes (e.g. removal of liver spots)
Intense light sources Laser devices	Ablative laser applications (e.g. skin resurfacing Removal of tattoos or permanent make-up
Ultrasound devices	Thermal tissue coagulation
Systems for stimulating the central nervous system in humans may only be used by licensed doctors who have the appropriate specialist knowledge after further medical training or advanced training.
Magnetic resonance tomographs may only be used for non-medical purposes in humans only under the responsibility of a doctor with specialist knowledge of the proper operation of magnetic resonance tomographs.

 

The NiSV constitutes several requirements for treatments allowed for aestheticians and alternative medical practitioners (and also for treatments by doctors).

 

Operational requirements

 

• Proper installation (applies to new devices and replacement devices);
•  Instruction of the user in proper handling (all relevant devices);
• Suitability test of the system by the user in relation to the respective application;
•  Condition check by the user before each use in terms of functionality and proper condition (inspection, checking connections, indicator lights, test run if necessary);
•  Maintenance by personnel who have the necessary technical knowledge, in particular through maintenance / inspection taking into account the information provided by the manufacturer and through compliance with the device-specific standards (inspection intervals);
• Advice and information to the customer before use by the user, in particular about application / effects / risks / side effects / alternatives / individual situation / possible need for prior medical clarification;
•  Protection against side effects / protection of third parties against harmful effects (e.g. spatial separation, restricted access).

 

Documentation

 

The regulation also stipulates new documentation requirements:

 

• Information on the identification of the system (e.g. invoices, device and maintenance books);
• Check the installation;
•  Briefing;
• Date and results of inspection / maintenance (maintenance book);
• Maintenance date; Date, type and consequences of malfunction;
• Documentation of advice, information and application (type / system used / treatment parameters / individual treatment plan / if necessary photo documentation / side effects);
• Declaration of consent of the treated person for use.

Notification to the competent authorities

 

The operator of a device/treatment covered by the NiSV must notify the competent authority of the operation of the device by stating

 

• the name or company of the operator,
• as well as the address of the permanent establishment and
• and providing information for the identification of the respective system.

 

Evidence must be attached to the notification that the persons using the system have the necessary expertise.

 

Devices that will be put into operation after December 31, 2021 must be reported to the authority within two weeks.

 

If a system is already in operation on December 31, 2020, the notification must be made by March 31, 2021.

 

Expertise and training requirements 

 

Expertise and training requirements for the users, must be fulfilled by December 31, 2021 at the latest

 

• Expertise can be acquired through successful participation in suitable training or through appropriate training and further education. It must be kept up to date. For this, participation in further training is required at least every five years;
• Training, education and advanced training can also take place in another EU country if the requirements are essentially comparable;

Expertise and Training requirements:

 

Devices/Treatments	Course	Units (45 min. each)
Intense light sources Laser devices	Basics of the skin and its appendages   This course is not necessary in the following cases:   User has   successfully completed state-recognized training as a aesthetician, has successfully completed a course of training as a state-certified aesthetician has successfully passed the master craftsperson examination in the cosmetics industry o on December 5, 2021 has at least five years of professional practice in the cosmetics industry.	80
Intense light sources Laser devices	Optical radiation	120
High-frequency devices	High-frequency	40
Ultrasound devices	Ultrasound	40
Low-frequency devices Direct current devices Magnetic field devices for transcutaneous electrical nerve stimulation or for muscle stimulation	Electromagnetic fields	24

 

Possible Sanctions in case of violations (subject are aestheticians and alternative practitioners, not manufacturers)

 

• Violations of the above requirements are an administrative offense that can be punished with a fine of up to EUR 50,000 per violation
•  In the event of violations, there are also threats to use bans and closings
• The NiSV does not contain criminal offenses, but in the case of bodily harm, non-compliance can result in negligence or even intent
•  Violations can also result in competition law warnings.

 

Please also be aware of the Alternative Medical Practitioners Act (Heilpraktikergesetz) in Germany. Anyone wishing to practice medicine without having been appointed as a doctor requires permission to do so. The practice of medicine in the sense of this law is any professionally or professionally performed activity for the detection, healing or relief of illnesses, ailments or bodily harm in people, even if it is carried out in the service of others. Purely cosmetic treatments can also be seen as practicing medicine, if (firstly) the activity generally requires medical expertise, and (secondly) the treatment - given a generalizing and typifying view of the activity in question - can cause significant health damage." This is to be determined by the German courts on a case-by-case basis. German courts are generally inclined to view treatments within the scope of the Act if the manuals of the devices state serious contraindications and side effects. The courts argue that aestheticians do not have the expertise to judge whether the treatments should be performed or not.

 

Also be aware of the new EU-Regulation on medical devices. The MDR also includes certain cosmetic devices without a medical purpose in its area of application. These are listed in Annex XVI of the MDR. These devices will be treated legally like products with a medical purpose, hence medical devices, and as such must go through the MDR conformity assessment procedure and be provided with a medical CE marking. In addition, special operator obligations then apply (if the NiSV does not already apply). However, the EU legislator will first have to issue so called “Common specifications” for these devices according to which the devices will have to be certified. Until then the devices are not deemed medical devices and do not have to undergo MDR conformity assessment.

 

Hamburg, April 5th, 2020

Rechtsanwalt Dr. Florian Meyer

(Attorney under German Law)