Post by Fresenius Kabi

A major MDR milestone for blood bag systems in Europe. 🩸 Fresenius Kabi’s blood donation and blood processing bag systems have been granted CE certification under the EU Medical Device Regulation (EU) 2017/745 (MDR) as Class III medical devices. As a first mover in the market to reach this MDR Class III certificate, we are proud to support European blood establishments with systems that meet the most stringent regulatory expectations. This matters because compared to the previous MDD Class IIb, the MDR upclassified these systems to Class III, placing them under the highest level of regulatory scrutiny, including strengthened clinical evaluation, traceability, and lifecycle oversight. What it means in practice: ✅ For patients: reinforced confidence in the quality of systems used to prepare blood components intended for transfusion. ✅ For blood services & transfusion professionals: assurance of solid clinical evidence, clear traceability, and full visibility across the product lifecycle - while staying aligned with MDR. ✅ For supply continuity & flexibility: certification covers systems manufactured with PVC/DEHP as well as DEHP-alternative materials. ➡️ Share this update with colleagues in QA/RA, blood services, and transfusion teams. #BloodDonation #CommittedToLife