- First-in-market MDR Class III CE certification supports supplier qualification and tender readiness for blood services with the European regulatory requirements.
- Certified portfolio covers PVC DEHP and DEHP alternative systems, enabling procurement flexibility and continuity of supply across established and transitioning material strategies.
- Compared to the previous MDD Class IIb, the MDR Class III certification strengthens auditability and lifecycle control through enhanced clinical evidence, full traceability, post market surveillance and notified body oversight—helping reduce regulatory risk for purchasers.
- For patients, MDR Class III certification reinforce confidence in the safety and reliability of blood collection systems that underpin transfusion therapies across Europe.
First-in-market: Fresenius Kabi achieves MDR Class III CE certification for blood donation systems, reaffirming its commitment to patient safety
May 4, 2026
Fresenius Kabi has obtained CE certification under the European Medical Device Regulation (EU) 2017/745 (MDR) for its blood donation systems following conformity assessment as Class III medical devices.
With this certification, Fresenius Kabi is the first blood bag manufacturer to obtain this MDR Class III CE certification, underlining its commitment to patient safety and supporting European blood establishments with a compliance-ready portfolio for tendering and long term supply planning.
Commenting on the MDR Class III certification, Wim Hermans, Senior Vice President Commercial Operations Fresenius Kabi MedTech Europe, said: “Achieving MDR Class III certification is a significant milestone for our blood donation systems. As the first blood bag manufacturer to achieve this certification, we are supporting blood services and procurement organisations with a robust compliance package for supplier qualification, audits and tender requirements—backed by strong clinical evidence, quality systems to ensure safety, performance and reliable supply.”
The MDR CE certificate confirms conformity with the General Safety and Performance Requirements and applies to both systems manufactured with PVC DEHP as well as systems made with DEHP alternative materials. This dual scope supports procurement flexibility and continuity of supply, helping blood services align tender specifications with local material policies while maintaining operational stability.
The MDR introduced a mandatory upclassification of blood donation systems from Class IIb to Class III, increasing regulatory requirements across the full product lifecycle. For blood services and procurement teams, this translates into tighter supplier qualification, more extensive technical documentation review, and increased expectations for traceability and post market surveillance. For patients, MDR Class III certification supports confidence in the safety and reliability of blood collection systems that underpin transfusion therapies across Europe. Compared with the former Medical Device Directive (MDD), the MDR requires enhanced clinical evidence, continuous notified body oversight, and full lifecycle controls that can directly impact tender specifications and contracting timelines.
About Fresenius Kabi
As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.
Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.
Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.
For more information, please visit www.fresenius-kabi.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.
Management Board: Pierluigi Antonelli (Chairman), Marc Crouton, Andreas Duenkel, Dr. Marc-Alexander Mahl, Dr. Sang-Jin Pak, Dr. Matthjis Groot Wassink
Chairman of the Supervisory Board: Michael Sen
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg - HRB 11654