B Medical Systems has become the first company worldwide in the industry of medical refrigeration and vaccine cold chain to obtain the new European Medical Device Regulation (MDR) certification.
“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”, said Luc Provost, CEO.
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. 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. According to the new European regulatory framework, this category of medical devices entails demanding clinical requirements and post-market surveillance.
While the Medical Device Directive (93/42/EEC) laid down a set of guidelines for local legislations, the new Medical Device Regulation (EU) 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. As of May 2021, the Regulation will be fully applicable to all medical devices that are being manufactured or imported in the European market.
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 American Association of Blood Banks (AABB) for its plasma storage freezers, contact shock freezers, and blood bank refrigerators.