A preliminary injunction issued by the District Court of Düsseldorf during MEDICA 2025, the world’s largest medical trade fair, has sharpened regulatory focus on platelet-rich plasma (PRP) devices, with implications extending beyond Europe into China and the United States.
According to a statement published by RegenLab SA, the District Court of Düsseldorf (Landgericht Düsseldorf, 14c Civil Chamber) issued an urgent preliminary injunction on 4 December 2025 against Beijing Hanbaihan Medical Devices Co, Ltd, also operating as Beijing Manson Technology Co, Ltd.
The order relates to PRP tubes exhibited at the trade fair that were not CE-marked under the EU Medical Device Regulation (EU MDR).
The injunction prohibits the placement of the PRP tubes on the German market unless a full MDR conformity assessment has been completed and a valid CE mark applied. It also restricts trade fair presentation of non-compliant products, unless they are clearly labelled ‘for exhibition only – not for clinical use’.
Each violation may attract fines of up to €250,000 or substitute detention. The injunction was granted urgently and is immediately enforceable in Germany.
EU implications for PRP systems
Under EU MDR, PRP and PRP plus hyaluronic acid systems supplied for clinical use must undergo the appropriate conformity assessment and CE marking pathway. Devices lacking MDR compliance cannot be marketed, supplied or clinically promoted within the EU.
While the ruling applies within Germany, it reflects increasing enforcement activity under MDR, particularly around devices that sit at the intersection of blood handling, preparation systems and therapeutic use.
China: prior enforcement and classification signals
The RegenLab statement also points to earlier regulatory action in China. In 2018, a Beijing FDA administrative penalty decision reportedly addressed the manufacture and sale of a ‘PRP kit’ treated as a Class III medical device without the required registration. That action included confiscation of illegal income and financial penalties.
In addition, the statement raises concerns around the scope of Export Sales Certificates (FSCs), noting that some FSCs authorise blood testing or examination use only, rather than therapeutic PRP preparation. Marketing PRP tubes for therapeutic use while relying on FSCs with limited authorisation scope may misrepresent regulatory status.
United States: marketing claims versus regulatory scope
Despite the EU injunction and cited Chinese enforcement actions, RegenLab notes that certain PRP tubes continue to be marketed in the United States as fully certified PRP systems, including claims of US FDA clearance.
The products are reportedly promoted through a range of commercial channels and distributor websites, including entities associated with aesthetic and regenerative medicine supply chains. RegenLab’s statement suggests that such marketing warrants closer scrutiny where regulatory authorisation scope, intended use and device classification may not align with promotional claims.
What this means for clinics and suppliers
Taken together, the developments highlight growing international divergence between marketing practices and regulatory enforcement for PRP devices.
For Australian clinicians and suppliers, the case serves as a timely reminder to critically assess international regulatory claims, particularly where EU MDR or FDA references are used to support clinical adoption of PRP systems.
The injunction is preliminary and may be subject to objection or appeal. However, it signals increasing regulatory attention on PRP devices across multiple jurisdictions, with implications for manufacturers, distributors and clinics operating in an increasingly globalised aesthetics market.
