VIDA PHARMA OBTAINS CE MARKING ACCORDING TO MDR FOR ITS OPÉRA® LINE

Successful transition to Regulation (EU) 2017/745 for all Opéra® Skinfiller and Skinbooster medical devices

Crespina Lorenzana (PI), 10 April 2026 – Vida Pharma, an Italian company active in the development and production of injectable medical devices and advanced dermocosmetics, announces that it has successfully completed the transition of the entire Opéra® line – including Skinfiller and Skinbooster – to the new European Regulation (EU) 2017/745 (MDR), obtaining CE certification in compliance with the most recent and stringent regulatory requirements.

The transition from the previous Directive 93/42/EEC (MDD) to the new MDR regulatory framework represents one of the most significant developments in the medical device sector in recent years. The MDR introduces significantly more stringent criteria for clinical evaluation, risk management, traceability, post-market surveillance, and quality control throughout the device's lifecycle, requiring manufacturers to adopt an even more structured and scientifically validated approach.

In this context, obtaining certification for the Opéra® line does not only represent a regulatory compliance, but a concrete recognition of the technological solidity, production quality and clinical reliability of Vida Pharma.

Internationally, the entry into force of the MDR is leading to a progressive selection of market operators, raising barriers to entry and rewarding companies capable of sustaining significant investments in research, development, and regulatory compliance. MDR compliance is now a strategic element for strengthening credibility with physicians, partners, and distributors, facilitating access to foreign markets, and consolidating competitive positioning in an increasingly regulated environment.

Starting in December 2027, it will no longer be possible to market Class III medical devices without MDR certification, making this compliance not only strategic but essential to ensure operational continuity and presence on European and international markets.

Dario Scaffai, CEO of Vida Pharma, commented:

"Achieving MDR certification for the entire Opéra® line represents a significant achievement for Vida Pharma. It's not simply a regulatory compliance measure, but a concrete confirmation of our commitment to the highest standards of safety, quality, and innovation. In an increasingly selective international environment, this milestone strengthens the scientific credibility of our devices and consolidates our role as a reliable partner for physicians and distributors globally."

With this important milestone, Vida Pharma continues its growth path, confirming an industrial vision based on research, internal development and integrated control of production processes, key elements to guarantee safe, high-performance medical devices that comply with the highest international standards.

Vida Srl.

Founded in 2004, Vida Pharma stands out on the market for the quality and innovation of its hyaluronic acid-based fillers and biorevitalizers for the face and body, as well as its cosmetics, including peels and mesotherapy, taking care of the entire production process, from raw materials to the finished product. The company markets its wide range of products under its own brand Ksurgery and through private label solutions, reaching the entire national territory and over 40 countries worldwide through selected partners. It is also the exclusive distributor of the Skeyndor brand

Vidapharma.it

For more information: 

VIDA Srl

Via Galileo Galilei n. 4

56040 Crespina Lorenzana (PI)

Tel.: +39 050 643 281 [email protected]

Internal press office: [email protected]