Stevanato Group's Ready-to-Use Prefilled Syringes Ensure Compliance with EU MDR Notified Body Requirements, Balancing Safety and Performance

Driven by advances in biotechnology, drug delivery systems, and emerging technologies, combination products comprising both pharmaceuticals and medical devices are rapidly gaining market share. These products not only enhance patient convenience in medication administration but also impose higher requirements for safety and efficacy. Meanwhile, as application scenarios continue to expand, regulatory frameworks are being progressively refined to support the development and approval of combination products. In particular, the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) sets forth clear requirements for combination products: pharmaceutical companies must ensure both the efficacy of the drug component and the safety and performance of the device component, thereby introducing new regulatory hurdles to market entry.

Under Article 117 of the Medical Device Regulation (MDR), if a medicinal product and a medical device constitute a single, non-reusable integral product, the device component must comply with the General Safety and Performance Requirements (GSPR) as confirmed by the opinion of a notified body. This requirement poses unprecedented challenges for Marketing Authorization Holders (MAHs): they must not only focus on the pharmacokinetic properties of drug-device combination products but also integrate the safety and performance aspects of the medical device component to ensure that the overall product complies with EU regulatory requirements.

Under a stringent regulatory environment, Stevanato Group’s ready-to-use pre-filled syringes (PFS) highlight its technical maturity in the field of combination products and its professional expertise in primary drug packaging and device design, ensuring that marketing authorization holders successfully obtain notified body opinions in compliance with the European Union Medical Device Regulation (MDR). Stevanato Group’s ready-to-use PFS products integrate advanced design concepts with high-standard manufacturing processes. The EZ-fill® ready-to-use, pre-sterilized packaging platform is widely applied in the biopharmaceutical sector; containers undergo pre-washing, depyrogenation, and pre-sterilization before reaching pharmaceutical or CDMO facilities, significantly streamlining aseptic production processes, enhancing overall production efficiency, and improving regulatory acceptance.

Among these, Stevanato Group’s Fina® and Nexa® series are both optimized to meet diverse needs. The Nexa® series is specifically designed for high-value pharmaceuticals, combining excellent mechanical resistance with superior aesthetic quality, dimensional tolerances, and surface properties to achieve maximum compatibility with filling systems. Meanwhile, the Fina® platform ensures consistent production quality in large-scale manufacturing through mature and validated processes. Alba® is a breakthrough solution designed for highly sensitive biologics or silicone-oil-sensitive biologics. It features a cross-linked coating technology based on standard silicone oil, which significantly reduces potential interactions between the drug and the container surface, thereby providing an excellent primary packaging solution for sensitive ingredients. The Nexa Flex™ polymer syringe, compatible with EZ-fill® configurations, is made from high-performance COC or COP materials. It offers outstanding aesthetic quality and fracture resistance, meeting the requirements for long-term storage and clinical use of sensitive drugs. These innovative designs not only ensure high compatibility between the device and the drug but also further enhance safety and convenience for patients.

Furthermore, by deeply understanding and strictly adhering to the MDR regulations, Stevanato Group leverages its accumulated technical advantages and supply chain integration capabilities. This enables the company not only to provide high-quality product solutions but also to offer reliable compliance support to global pharmaceutical companies in a complex regulatory environment. By helping clients successfully navigate the EU’s intricate regulatory requirements, Stevanato Group reduces approval risks and time costs, thereby promoting the standardization of product development.

As a global leader in drug delivery and primary packaging solutions, Stevanato Group remains committed to innovation and compliance at its core, dedicated to providing pharmaceutical companies with high-quality, user-friendly, and regulatory-compliant solutions. Looking ahead, Stevanato Group will continue to leverage its technological strengths in drug delivery systems and medical device portfolios, helping global pharmaceutical companies enhance product safety and patient medication experiences, thereby contributing to public health and medical innovation.