First-in-market: Fresenius Kabi achieves CE certification for blood donation systems under MDR class III

Fresenius Kabi announces that its blood donation systems have been granted the CE certification in accordance with the European Medical Device Regulation (EU) 2017/745 (MDR), following conformity assessment as Class III medical devices. Fresenius Kabi is the first blood bag manufacturer to achieve this MDR Class III CE certification, signaling Fresenius Kabi’s commitment to patient safety in blood transfusion.

For transfusion professionals and blood services, MDR certification provides assurance of strong clinical evidence, traceability, and lifecycle oversight.

For patients, it reinforces confidence in systems used for the preparation of blood components intended for transfusion.

Wim Hermans, Senior Vice President Commercial Operations Fresenius Kabi MedTech Europe, said: “Achieving MDR Class III certification is a landmark moment for Fresenius Kabi and our blood donation systems. As the first blood bag manufacturer to achieve this certification, we are setting a new benchmark for quality and regulatory excellence. For clinicians and transfusion teams across Europe, it reinforces confidence in the safety, performance and reliability of the systems that underpin everyday transfusion care”

The certification scope includes blood bag systems manufactured with PVC‑DEHP as well as systems made with DEHP‑alternative materials, supporting established clinical practice while addressing evolving regulatory and material considerations in European blood establishments.

Under the MDR, blood donation systems are up classified from Class IIb to Class III, reflecting their critical role in the collection, processing, storage, and transfusion of blood and blood components. Class III devices are subject to the highest level of regulatory scrutiny, including comprehensive clinical evaluation, benefit–risk assessment, and enhanced notified body oversight.

The MDR CE certificate confirms conformity with the General Safety and Performance Requirements set out in Annex I of the MDR and verifies compliance of Fresenius Kabi’s quality management system, technical documentation, and post-market surveillance processes with the requirements for Class III medical devices across the entire product lifecycle.

For the full list of products that meet this requirement, please click on the download below. 

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.

Visit our company page to find out more information.

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, Matthjis Groot Wassink

Chairman of the Supervisory Board: Michael Sen Registered Office: Bad Homburg, Germany Commercial Register: Amtsgericht Bad Homburg - HRB 11654

Job Code: GB - BTP- 2600003  June 2026 

Intended for UK Healthcare Professionals