The Regulatory Gold Standard — MDR and Annex XVI
Germany operates under the strictest medical device oversight in the world, following the full implementation of the EU Medical Device Regulation (MDR). In 2026, dermal fillers are classified as Class III high-risk medical devices, regardless of whether they have a medical or purely aesthetic purpose.
This means every filler on the German market has undergone rigorous clinical evaluations and is tracked via a "Unique Device Identification" (UDI) system to ensure total traceability.
Furthermore, Annex XVI of the MDR specifically targets products without a medical purpose, ensuring they meet the same clinical safety and performance requirements as life-saving implants. In Germany, the BfArM (Federal Institute for Drugs and Medical Devices) mandates that only licensed medical professionals—primarily doctors and specialized alternative practitioners (Heilpraktiker)—can administer these injections. This regulatory barrier has effectively reduced the prevalence of "black market" fillers and improved the overall safety profile of the German aesthetic industry.