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B Medical Systems Becomes First Medical Refrigeration Manufacturer to Gain EU MDR Certification
B Medical Systems, a Luxembourg-based pioneering manufacturer of medical devices, has become the first company worldwide in the medical refrigeration and vaccine cold chain industries to obtain the new European Medical Device Regulation certification (EU MDR).
Following a rigorous conformity assessment of its quality management system and technical documentation, the notified body TÜV SÜD issued the EU Certificate according to the MDR (EU) 2017/745 for B Medical Systems’ medical devices.
Demanding clinical requirements
Designed for the safe management of highly sensitive blood components, B Medical Systems’ blood bank refrigerators, plasma storage freezers, ultra-low freezers, and contact shock freezers are classified as medical devices Class IIa, subject to more demanding clinical requirements and post-market surveillance under the new European regulatory framework.
The new EU MDR regulation will be fully applicable to all medical devices that are manufactured in or imported to the European market from May 2021.
While the Medical Device Directive (93/42/EEC) laid down a set of guidelines for local legislations, the new EU MDR 2017/745 is legally enforceable in each Member State of the European Union. It aims to guarantee a greater level of safety, quality and performance for both end-users and patients, and to increase transparency on medical devices across the EU.
B Medical Systems’ CEO, Luc Provost, commented: “B Medical Systems has always been committed to providing reliable medical devices that meet the highest standards of quality and safety for both users and patients. Our teams took early action and redoubled efforts to transition to the MDR and comply with the new requirements applicable in the European market. By becoming an early adopter of the new Regulation, we reinforce our position as leader in the industry.”
The MDR certification adds an extra layer of quality assurance for B Medical Systems’ equipment. At the end of 2019, B Medical Systems also succeeded in obtaining the SCoPE accreditation granted by the AABB (former American Association of Blood Banks) for its plasma storage freezers, contact shock freezers, and blood bank refrigerators.
About B Medical Systems
B Medical Systems S.à r.l. is a Luxembourg-based manufacturer and global distributor of certified medical devices with more than 40 years of experience.
As a market leader for the vaccine cold chain industry, B Medical Systems contributes to the success of immunization programs in developing countries.
The company also produces a complete range of high-end medical refrigeration and blood management solutions for the cold storage and transportation needs of blood banks, hospitals, pharmacies, laboratories, and the pharmaceutical industry.
B Medical Systems – Saving lives through reliable and innovative technology
Further information at: www.bmedicalsystems.com