Beauty tech and medical device law: Who is allowed to use which devices?

Device-based beauty and anti-aging treatments using lasers, IPL, radiofrequency, ultrasound, or focused ultrasound have evolved from a specialized offering of individual practices to a broad market. With this market growth, legal requirements have also increased. Some devices are now classified as medical products, many applications are subject to the German Radiation Protection Ordinance (NiSV), and certain treatments may only be performed by licensed physicians. Anyone offering a treatment that is not permitted for their professional group risks warnings, fines, and official prohibitions.

For manufacturers, distributors, associations, training providers, and users, the same question therefore arises time and again: Who is allowed to use which device for which purpose, and how can this boundary be legally established? The answer cannot be found in a single law, but rather in the interplay of cosmetics law, medical device law, and radiation protection law. It is often unclear, especially at the interfaces between these regulations, what currently applies.

Life Sciences Law assists you in legally classifying your devices and applications, from intended purpose and approval to advertising. The guiding principle is the purpose to which all these regulations are aligned: the protection and safety of the people being treated.

Beautytech between cosmetics, medical device and radiation protection

Beautytech devices cannot be categorically assigned to a single legal area. Depending on their intended purpose, mode of operation, and application, different sets of regulations apply, some of which overlap.

Three levels are crucial:

• Cosmetics law: Pure cosmetic products and cosmetic treatments without radiation effects are governed by the EU Cosmetics Regulation (EC) No. 1223/2009 and national cosmetics law.
• Medical Device Law: If a device serves a medical purpose, the Medical Device Regulation (EU) 2017/745 (MDR) applies, together with the German Medical Devices Law Implementation Act (MPDG). Since June 22, 2023, the MDR has also covered certain products without a medical purpose via its Annex XVI.
• Radiation Protection Act (NiSV): The use of devices with non-ionizing radiation for cosmetic and other non-medical purposes is regulated by the NiSV, based on the law on protection against non-ionizing radiation in applications on humans (NiSG).

These regulations pursue different objectives. Medical device law primarily concerns the product itself, i.e., development, approval, labeling, and placing on the market. The German Radiation Protection Ordinance (NiSV) concerns the application to humans and thus the question of who may use a device and under what conditions. Only the interplay of both levels provides the complete picture, and this is precisely where most uncertainties arise.

Who is allowed to use which beauty tech device?

The German Radiation Protection Ordinance (NiSV), which has been in effect since December 31, 2020, and was amended in 2023, is the relevant regulation for the use of devices on humans for cosmetic purposes. It applies to commercial applications of laser devices, intense light sources, high-frequency, ultrasound, low- and high-frequency stimulation devices, and magnetic field devices for cosmetic or other non-medical purposes. Treatments for medical purposes are generally not covered by the NiSV. However, they may be subject to medical professional regulations, the regulations governing alternative practitioners, medical device regulations, and other health-related regulations, as not every medical treatment is necessarily performed by physicians.

The NiSV essentially distinguishes three constellations:

• Applications requiring specialist expertise: Treatments such as permanent hair removal with laser or IPL, as well as many high-frequency, ultrasound, and stimulation applications, may only be performed by those who provide the required proof of expertise. Permanent hair removal is explicitly not reserved for physicians.
• Applications subject to medical supervision: Certain higher-risk treatments may only be performed by licensed physicians with appropriate advanced training or further education.
• Medical delegation: The requirement that a physician prescribe treatment does not preclude the physician's right to delegate tasks. Under certain conditions, a physician may delegate individual steps to qualified assistants. However, the responsibility for the treatment remains with the physician, and a duty of supervision exists.

An often overlooked distinction is important: the requirement for a doctor's prescription relates to the specific application, not the device itself. Therefore, there is no general requirement for a doctor's prescription for specific devices per se. What matters is the treatment actually being performed. With the same device, one application may be permitted while another requires a doctor's prescription.

There is no blanket authorization for alternative practitioners and other non-medical professionals. Most treatments that are reserved for physicians may not be performed independently by alternative practitioners. In addition to medical licensure, the specific risks involved in the procedure and legal restrictions are also decisive factors. Whether a specific treatment is permissible depends on the particular application, the medical prescription requirement, and the professional regulations, and must be examined on a case-by-case basis.

Before using or distributing a device, clarify which professional group is legally authorized to use it. Get in touch.

Applications subject to medical supervision: the red line

Since December 31, 2020, certain procedures may only be performed by licensed physicians. The regulation does not restrict this to specific medical specialties, but requires appropriate medical training or continuing education.

The following are among the items subject to medical prescription:

• Tattoo and permanent makeup removal: with lasers or similar methods.
• Treatment of vascular changes: for example, spider veins or couperose with optical radiation.
• Treatment of pigmented skin lesions: insofar as it is done with lasers or intense light sources.
• Ablative laser applications: as well as all applications where the integrity of the epidermis as a protective barrier is compromised.
• Fat tissue reduction: with optical radiation, high frequency or ultrasound, i.e. applications whose effect is not limited to the skin.

Similar applications using high frequency or ultrasound are also restricted. Anyone offering or advertising such treatments without a medical license is acting illegally. Since the line between a cosmetic procedure and one that is already reserved for medical practitioners can be fluid in individual cases, a careful legal assessment of the specific treatment offered is essential.

Expertise, display and documentation: the obligations of users

For applications not subject to medical prescription, the NiSV (German Ordinance on Non-Ionizing Radiation Protection) requires proof of specialist knowledge. These regulations have been in effect since December 31, 2022. In addition, there are notification and documentation obligations, the enforcement of which is the responsibility of the individual federal states.

The following obligations must be observed:

• Certificate of expertise: Expertise according to the modules of Annex 3 of the German Radiation Protection Ordinance (NiSV) is required, evidenced by a certificate from an accredited conformity assessment body (§ 4a NiSV). According to the transitional provision of § 13 NiSV, suitable training certificates were also sufficient until the end of 2025. Since January 1, 2026, mere certificates of training or attendance are no longer sufficient; already issued valid certificates remain valid. The enforcement authorities of the federal states are responsible for the specific application of this requirement.
• Personal data: Expertise is tied to the individual. Every person who operates an affected device requires their own certification. A one-time training session for management is not sufficient.
• Display of devices: The operation of an affected plant must be reported to the responsible authority no later than two weeks before commissioning.
• Combination devices: Anyone using a device that combines several techniques, such as intense light source and high frequency or ultrasound, must demonstrate expertise in each individual method.
• Update: Professional expertise must be kept up-to-date through regular refresher training.

Because responsibilities vary from state to state and documentation requirements have recently become stricter, it is worthwhile to check your own compliance before an official audit takes place.

When the effect determines the legal situation

Whether a device is classified as a purely cosmetic device, a treatment requiring professional expertise, a treatment reserved for physicians, or a medical device cannot be determined from the product name or advertising claims. The decisive factors are its technical specifications and its actual effect on the body. As a general guideline: the deeper a device penetrates the skin and the higher the energy output, the more likely it is to be subject to strict regulations or require medical supervision.

The following factors are particularly important for the classification:

• Penetration depth and energy density: Treatments that reach deeper layers of skin, damage the skin barrier, or operate with high energy flux density are regularly classified more strictly than superficial applications.
• Physical mechanism of action: The decisive factor is the actual mode of operation. Devices that do not use non-ionizing radiation, such as cryolipolysis via cold or certain plasma pens via thermal effects, are not covered by the NiSV (German Radiation Protection Ordinance), but may be subject to other regulations.
• Manufacturer's intended purpose: Whether a product serves a cosmetic or a medical purpose is determined by its intended purpose. This determines which regulations apply.
• Annex XVI of the MDR: Certain non-medical products have been subject to the MDR (Medical Device Regulation) since June 22, 2023. These include, among others, devices for liposuction and fat reduction, as well as laser and IPL (Intense Pulsed Light) devices for skin treatment and hair removal. Classification depends on the specific product and the MDR classification rules; devices that emit electromagnetic radiation for skin treatment are often classified in higher risk classes, such as IIb.

This classification is not a mere formal step, but rather determines the entire compliance chain: approval process, labeling, authorized user group, and permitted advertising. An error at this stage affects all subsequent obligations.

Manufacturers and distributors of beauty tech devices

Anyone who develops, manufactures, imports, or distributes devices for cosmetic or aesthetic medicine is responsible for ensuring that the product is correctly classified, labeled, and advertised. It is important to distinguish between the relevant legal areas: the German Radiation Protection Ordinance (NiSV) regulates use on humans, not placing the product on the market. Medical device law and product safety law are the governing regulations for making the product available on the market.

The focus for manufacturers and distributors is on:

• Intended use and classification: The precise definition of the intended purpose determines whether a product is to be classified as a cosmetic device, a medical device or as a product according to Annex XVI of the MDR.
• Conformity and CE marking: If a device falls under the MDR, technical documentation, risk management, conformity assessment, and, depending on the risk class, the involvement of a notified body are required. For products listed in Annex XVI, the common specifications of Implementing Regulation (EU) 2022/2346 apply.
• Labeling and instructions for use: Products not intended for medical use must be labelled as such. The instructions for use should include information on required qualifications and limitations of use. However, which professional group is actually permitted to use a device under German law is determined by the German Radiation Protection Ordinance (NiSV), professional regulations, and other legal requirements, not solely by the manufacturer's information.
• Application interface: Device information, instructions and guidelines on technical expertise should be prepared in such a way that users can meet the requirements of the NiSV (German Ordinance on Non-Ionizing Radiation Protection).

Thorough product documentation is the most effective protection against future disputes. It clarifies what a device is permitted to do and who is allowed to use it, and it forms the basis for legally compliant marketing.

Ensure the intended purpose and permissible user group of your devices are clarified early on. Get in touch and secure your market strategy.

Warnings, fines and official measures

In practice, conflicts often arise when providers offer or promote treatments that are not permitted for their professional group. Doctors and competitors are increasingly taking action against such offers, and regulatory authorities are stepping up their monitoring.

Typical risks include:

• Warnings under competition law: If treatments reserved for doctors are advertised or performed by non-doctors, warnings and cease-and-desist orders are threatened, often associated with considerable costs.
• Fines: Violations of the NiSV can be punished as administrative offenses with fines.
• Official prohibition: A lack of expertise or impermissible applications discovered during an inspection can lead to the operation of individual devices being prohibited.
• Confirmation by the courts: Several administrative courts, including the Bavarian Administrative Court, have upheld the requirement of a physician's authorization under the German Non-Ionizing Radiation Protection Ordinance (NiSV), for procedures such as laser removal of tattoos and permanent makeup. Legal challenges against this have been unsuccessful in these cases.

Precisely because the distinction is difficult in individual cases, business models, treatment offers and website texts should be legally reviewed before a warning or complaint arrives in the mailbox.

Before accepting a warning or complaint: Have your service offerings and public image reviewed.

Associations and manufacturers: Securing and further developing application areas

The beauty tech industry is evolving faster than the law. Associations, manufacturers, and training providers are advocating for qualified professionals outside the medical profession to be legally permitted to perform certain procedures or for viable delegation models to be established. Such initiatives touch upon regulatory, professional, and political issues simultaneously.

Life Sciences Law provides support in areas including:

• Regulatory location assessment: Which applications are already permitted under current law, and where is the limit of the medical prescription requirement?
• Statements and position papers: Technically sound argumentation vis-à-vis authorities, ministries and in the context of hearings.
• Qualification and training concepts: Legally compliant design of specialist knowledge and training programs that meet the requirements of the NiSV and the specialist knowledge guideline.
• Delegation and cooperation models: Shaping the collaboration between doctors and non-medical professionals within the bounds of the law.
• Industry standards: Developing robust standards that balance patient safety and business interests.

Precisely because it is often unclear what currently applies, a sound legal classification is the basis of any serious initiative for the further development of the approval process.

Advertising and HWG: what beauty tech providers are allowed to promise

As soon as a device or treatment pursues a health-related purpose, the German Act on Advertising of Therapeutic Products (HWG) comes into play, in addition to competition law. Advertising claims regarding efficacy, safety, and application must be legally sound and must not be misleading.

Those who are particularly sensitive are:

• Promise of effectiveness: Statements regarding treatment success must be verifiable and must not raise unrealistic expectations.
• Distinguishing between experts and laypersons: Different standards apply to advertising aimed at medical professionals than to advertising aimed at consumers.
• Before-and-after comparisons: Pictorial representations are subject to special restrictions in the field of health-related applications.
• Online sales and social media: Posts on social networks and booking platforms are also considered advertising in the legal sense and must comply with the regulations.

I review your communication to ensure it remains legally compliant while still effectively reaching your target audience.

Patient safety as a benchmark

Behind all regulations concerning beauty technology lies a common underlying principle: the protection of the people being treated. The requirement for a doctor's referral, the obligation of expertise, and the requirements of the MDR are not ends in themselves, but rather respond to real risks, from burns and scarring to overlooked illnesses, such as when a pigmented skin lesion is treated without medical consultation.

Those who take this protection goal seriously will also be able to argue more convincingly with authorities, courts, and business partners. A legally compliant statement is therefore not only a legal obligation, but also a mark of quality and a sign of trust with customers.

Why Life Sciences Law in Beautytech Law?

Life Sciences Law combines specialized legal advice with many years of management experience in the life sciences industry. Attorney Ralph Schäfer has been admitted to the bar for 27 years and has served as General Counsel, Compliance Officer, and board member in international, publicly listed medical technology, biotech, and pharmaceutical companies.

This means for you:

• Interface expertise: A sound understanding of the boundaries between cosmetics, medical devices, and medical treatment.
• Practical relevance: Consulting that combines regulatory requirements with the actual processes in companies, practices and institutions.
• Strategic perspective: Solutions that are legally sound, economically viable, and feasible in everyday life.
• Reliable support: from a one-off assessment to ongoing regulatory support.

The law firm stands for personal, pragmatic and ethically oriented support in the highly regulated environment of aesthetic medicine and beauty tech.

Call or write to us. Together we'll determine which devices and applications are legally compliant for you.