Hyaluronic pen before the administrative court: What the Düsseldorf preliminary ruling on the IRI filler system means

In a widely noted ruling dated June 12, 2025, the Düsseldorf Administrative Court decided that two beauticians may use and advertise the so-called IRI filler system without a naturopathic practitioner's license (Case No. 20 L 1075/25). The decision was issued in preliminary injunction proceedings and is not yet legally binding. It concerns a specific, needle-free application system and cannot be readily applied to all hyaluronic pens. Precisely for this reason, a closer look is warranted, as the legal assessment for manufacturers, distributors, and associations hinges on the details.

What was it about?

The IRI-Filler system involves injecting hyaluronic acid, the so-called IRI-Filler, into the skin under high pressure using a needle-free application device, the IRI-Pen. Lip and facial wrinkle treatments were offered using this system. The city of Solingen considered this a medical practice requiring a license and prohibited two beauticians from both performing the treatment and advertising it. The authorities argued that the treatment required basic medical knowledge, which the beauticians lacked, due to potential health risks. The affected parties appealed this prohibition order in expedited proceedings.

The decision of the Düsseldorf Administrative Court

The 20th Chamber of the Administrative Court granted the application for an injunction. It ruled that the practice of medicine within the meaning of the German Law on Non-Medical Practitioners (Heilpraktikergesetz) was not present, because the treatment did not require any medical expertise but was a purely cosmetic activity. The application of the IRI filler system was not comparable to medical wrinkle injections.

The court's decisive factor was that the upper layers of skin were not damaged and that no particular risks beyond the general risks of cosmetic treatments were to be expected. Since the prohibition was unlawful according to the findings of the preliminary injunction proceedings, the advertising ban was also deemed untenable. The city of Solingen can appeal the decision, which will be decided by the Higher Administrative Court for the State of North Rhine-Westphalia in Münster.

Why the decision does not apply to all hyaluronic pens

The decision is being interpreted in some parts of the beauty tech industry as a general authorization for beauticians. This is too simplistic. Several points need to be considered:

• Expedited proceedings instead of the main issue: The decision is based on a summary review and is not legally binding. The Higher Administrative Court may assess the matter differently.
• A specific case study of a particular system: The crucial point was that, according to the findings, this system only reaches the outermost layer of skin. Therefore, the decisive factor is not the term "hyaluron pen," but the actual application depth and effect.
• Restrictive baseline: When hyaluronic acid is injected into deeper layers of the skin, or when the method is comparable to dermal fillers, there is a strong argument for it being considered medical practice. Several authorities, such as the North Rhine-Westphalia Ministry of Health, have classified hyaluron pen applications as medical practice in the past.
• Criminal risk: Anyone practicing medicine without a medical license or a permit as a non-medical practitioner is liable to prosecution under Section 5 of the German Non-Medical Practitioners Act. Therefore, the distinction in each individual case is of considerable importance.
• Proof required: It must be proven that a method only reaches the epidermis, in practice regularly through studies or expert opinions.

The Düsseldorf ruling is in line with a series of decisions specifically concerning the original IRI system. The Minden Administrative Court had previously ruled similarly for this system. No conclusions can be drawn from this ruling regarding other devices, other fillers, or deeper applications.

Cosmetic product or medical device? The product law dimension

Besides the question of who is allowed to perform the treatment, the classification of the product itself is crucial. Here, the distinction between cosmetics and medical devices is decisive:

• Dermal fillers as a medical device: Substances introduced into the body to modify the skin are considered medical devices under Annex XVI, No. 3 of the Medical Devices Regulation (EU) 2017/745, even without a specific medical purpose. Hyaluronic acid for intradermal application is therefore frequently certified as a high-risk medical device.
• Cosmetic classification in individual cases: In 2019, the Düsseldorf district government had already determined that the IRI system and fillers were cosmetic products and not medical devices, because the hyaluronic acid was introduced exclusively into the epidermis.
• Purpose determines: For manufacturers, this means: The intended purpose and the actual depth of application determine whether a product is to be classified as a cosmetic or as a medical device according to Annex XVI MDR, and thus determines CE marking, permissible user group and allowed advertising.

The German Radiation Protection Ordinance (NiSV) does not apply to hyaluron pens, as these devices do not use non-ionizing radiation on humans. The assessment is based solely on the laws governing alternative medicine practitioners, medical devices, and competition law.

Advertising and risk of legal warnings

Even after the Düsseldorf ruling, advertising hyaluronic pen treatments remains a sensitive area. Anyone offering such a treatment without clearly stating the specific method used and the application depth risks legal warnings under competition law and violations of the German Act on Advertising of Therapeutic Products. Specialized law firms regularly issue warnings to such offers. In particular, advertising must not create the impression of a medical injection if, in reality, only a superficial cosmetic application is performed. Furthermore, recent case law has narrowed the permissible scope of before-and-after photos for aesthetic treatments.

What manufacturers, suppliers and associations should now consider

Concrete action steps can be derived from the decision:

• Demonstrate application depth: Anyone relying on a purely cosmetic classification should be able to prove through studies or expert opinions that the method only reaches the epidermis.
• Correctly classify the product: Clarify the intended purpose and classification, including whether the filler falls under Annex XVI of the MDR.
• Document application and training: Training concepts and application instructions should be appropriate for cosmetic classification and be comprehensibly documented.
• Design advertising with clear methods: Clearly indicate which method is being offered and avoid any appearance of medical treatment.
• React to prohibitions early: As this case shows, effective action can be taken against official prohibition orders even in expedited proceedings.

Conclusion

The ruling by the Düsseldorf Administrative Court strengthens the position of providers of a specific, needle-free system that acts solely on the epidermis. However, it is not a carte blanche for all hyaluronic pens. The legal assessment still depends on the actual effect on the skin, the product's classification, and clear communication of the methodology. As long as the Higher Administrative Court has not ruled and the main issue remains unresolved, the safest course of action is a thorough legal review of the specific device, the treatment, and its public presentation. As with all beauty tech issues, the safety of the treated individuals is the primary consideration.

Are you a manufacturer, supplier, or association in the field of aesthetic applications and would like to have your device, treatment, or advertising legally classified? Contact Life Sciences Law.