10/04/2026
A new chapter for Opéra® with MDR CE marking
Vida Pharma has successfully completed the transition of its entire Opéra® line (Skinfillers and Skinboosters) to the European Medical Device Regulation (EU) 2017/745 (MDR), achieving CE marking under MDR in line with the latest regulatory standards.
This milestone goes far beyond a simple regulatory update.
The new framework introduces significantly more stringent requirements in terms of clinical evaluation, safety, traceability and quality control, reshaping the standards for the entire medical device industry.
In this context, MDR compliance represents a concrete guarantee of reliability for physicians and patients, while also playing a key role in accessing international markets and standing out in an increasingly selective environment.
From December 2027, Class III medical devices without MDR CE marking will no longer be allowed on the market.
A milestone that confirms Vida Pharma’s commitment to quality, innovation and scientific rigor.
As highlighted by CEO Dario Scaffai:
“This is not simply a regulatory transition, but a clear confirmation of our commitment to the highest standards of safety, quality and innovation.”
Vida Pharma continues its growth journey by investing in research, development and full control of its production processes, with the goal of delivering increasingly reliable and high-performing solutions for aesthetic medicine.
