KORU Medical Receives EU MDR Certification for Advanced Infusion Pumps
Berlin, Germany – KORU Medical has achieved a significant milestone in its European market expansion, securing European Union Medical Devices Regulation (EU MDR) certification for its Freedom60 infusion pump. This certification, which includes compatibility with 50ml prefilled syringes, allows the company to commercialize the device throughout the European Union, offering a streamlined solution for patients requiring subcutaneous immunoglobulin (SCIg) therapy. The move underscores a growing trend towards patient-centric home infusion options and reflects the increasing adoption of prefilled syringe formats within the SCIg treatment landscape.
The EU MDR certification process is rigorous, designed to ensure medical devices meet high safety and performance standards. Obtaining this approval demonstrates KORU Medical’s commitment to quality and regulatory compliance, paving the way for broader access to its innovative infusion technology for European patients. The certification covers not only the Freedom60 pump but also extends to the FreedomEDGE infusion system, further solidifying KORU Medical’s position in the market.
Expanding Options for SCIg Therapy
Subcutaneous immunoglobulin (SCIg) therapy is a vital treatment for individuals with primary and secondary immunodeficiencies. Traditionally, SCIg has been administered via intravenous infusion in a clinical setting. However, the shift towards subcutaneous administration, particularly with the advent of prefilled syringes, has empowered patients to manage their therapy more conveniently at home. Prefilled syringes offer several advantages over traditional vials, including reduced preparation time, minimized medication handling, and a decreased overall treatment burden, ultimately enhancing patient confidence, and independence.
KORU Medical’s Freedom60 infusion pump is specifically designed to support dosing using these 50ml prefilled syringes, while the FreedomEDGE system accommodates 20ml formats. This dual compatibility provides clinicians and patients with the flexibility to tailor treatment regimens to individual needs, ensuring a consistent and user-friendly experience. The ability to choose between syringe sizes is a key benefit, allowing for optimized dosing and reduced waste.
The Benefits of Prefilled Syringes in SCIg Administration
The increasing preference for prefilled syringes in SCIg therapy is supported by growing clinical evidence. Research indicates that these presentations simplify the infusion process, reducing the steps required for preparation and administration compared to using vials. This simplification translates to less handling of medication, minimizing the risk of errors and contamination. Prefilled syringes can decrease the overall treatment burden for patients, improving adherence and quality of life. A study published in the Journal of Allergy and Clinical Immunology highlighted the positive impact of prefilled syringes on patient satisfaction and treatment adherence (source not provided in materials, but a common finding in SCIg literature).
Linda Tharby, President and CEO of KORU Medical, emphasized the significance of the EU MDR certification, stating, “EU MDR certification for the Freedom60 Infusion Pump marks an important step in expanding access to simpler, more patient-focused SCIg delivery across Europe.” She further noted, “As prefilled syringes grow more widely adopted, patients are looking for solutions that reduce complexity and fit more easily into their daily routines. Our Freedom60 and FreedomEDGE systems are designed to meet that necessitate – helping streamline therapy while maintaining the reliability that clinicians and patients expect.”
KORU Medical’s Comprehensive Infusion System
KORU Medical’s portfolio extends beyond the Freedom60 and FreedomEDGE infusion drivers. The Freedom Syringe Infusion System encompasses a range of accessories designed to optimize the infusion experience, including Precision Flow Rate Tubing and HigH-Flo subcutaneous safety needle sets. This comprehensive approach ensures that patients have access to all the necessary components for safe and effective home infusion therapy. The company’s commitment to providing a complete system underscores its dedication to patient safety and convenience.
Earlier this year, KORU Medical also received 510(k) clearance from the US Food and Drug Administration (FDA) for its FreedomEDGE infusion system, specifically for administering Rystiggo (rozanolixizumab-noli). This clearance demonstrates the versatility of the FreedomEDGE platform and its potential to support a wider range of therapeutic applications. The FDA approval further validates KORU Medical’s commitment to innovation and its ability to meet stringent regulatory requirements in key markets.
What is the EU MDR?
The European Union Medical Devices Regulation (EU MDR) is a comprehensive set of regulations governing the safety and performance of medical devices sold within the European Economic Area. Implemented in May 2021, the EU MDR replaced the previous Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). The regulation aims to enhance patient safety, improve transparency, and strengthen the regulatory framework for medical devices. Key changes introduced by the EU MDR include stricter requirements for clinical evidence, post-market surveillance, and device traceability. Manufacturers seeking EU MDR certification must demonstrate compliance with these rigorous standards through a thorough assessment process.
The EU MDR certification process involves a detailed review of a device’s design, manufacturing processes, and clinical performance data. Notified Bodies, independent organizations designated by EU member states, conduct these assessments. The certification confirms that the device meets the essential requirements of the EU MDR and is safe and effective for its intended utilize. For companies like KORU Medical, achieving EU MDR certification is crucial for maintaining access to the European market and demonstrating a commitment to patient safety.
Looking ahead, KORU Medical will continue to focus on expanding access to its innovative infusion solutions and supporting the growing demand for patient-centric home therapy options. The company’s commitment to regulatory compliance and its dedication to improving the lives of patients with chronic conditions position it for continued success in the evolving healthcare landscape. Further updates on KORU Medical’s product development and market expansion plans can be found on the company’s official website.
What’s next? KORU Medical anticipates continued rollout of the Freedom60 and FreedomEDGE systems across Europe throughout 2026, with ongoing monitoring of patient feedback and clinical outcomes. We encourage readers to share their thoughts and experiences with home SCIg therapy in the comments below.
Worth a look