This follows completion of the updated conformity assessment process required under MDR, which replaces the previous Medical Device Directive and imposes enhanced safety, performance and quality requirements for medical devices in the EU.   

Under the new MDR certification, Sculptra can now be used in the gluteal region, posterior thighs, décolletage and upper arms, enabling clinicians to address a broader range of aesthetic goals, such as improving skin quality (including reduction in the appearance of cellulite), enhancing firmness, lift, projection and contour across all three skin layers.   

Clinical data referenced by Galderma show progressive improvements in treated areas, with visible changes in texture and firmness reported as early as one month after treatment in some cohorts. Satisfaction rates among patients and physician-rated improvement scores were high in studies of the gluteal area, thighs, décolletage and upper arms.   

Galderma describes the expanded certification as part of an evolution in injectable aesthetics, reflecting shifting patient expectations for holistic, full-body approaches to regenerative care that extend beyond traditional facial rejuvenation. This expanded indication also reinforces Sculptra’s positioning as a regenerative biostimulator that works by stimulating endogenous collagen production to support gradual and sustained improvements in skin structure and quality.