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.
Dr. Meyer was admitted to the bar in 2004. He studied in Hamburg, Lower Saxony and Freiburg and completed his doctorate on the topic health claims in Europe and the U.S.. He is the author of a book on the European Health Claims Regulation and other specialized publications. Since 2006, he is also a speaker at the Food Law Academy at the University of Marburg, a member of the Scientific Advisory Board of the Marburg Research Centre for Food and Feed Law and a winner of the food law Prize 2005 (pmi Verlag). In addition, he is on the advisory board of the magazine Medical BEAUTY FORUM and mentor at the Food Tech Campus Berlin on food and data protection issues.
Experience (excerpt):
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
Non-ionizing radiation includes
The following devices fall within the Regulation:
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 |
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Intense light sources Laser devices High-frequency devices |
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Intense light sources Laser devices |
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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. |
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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. |
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The NiSV constitutes several requirements for treatments allowed for aestheticians and alternative medical practitioners (and also for treatments by doctors).
Operational requirements
Documentation
The regulation also stipulates new documentation requirements:
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
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 and Training requirements:
Devices/Treatments |
Course |
Units (45 min. each) |
Intense light sources Laser devices
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Basics of the skin and its appendages
This course is not necessary in the following cases:
User has
|
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)
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)