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16 Feb 2023 - 18 Feb 2023

Mindray Defibrillators Amongst the World’s First to Receive MDR Clearance

By HospiMedica International staff writers
Posted on 23 Jan 2023
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Image: The BeneHeart series defibrillators have earned accreditation for their quality and effectiveness (Photo courtesy of Mindray)
Image: The BeneHeart series defibrillators have earned accreditation for their quality and effectiveness (Photo courtesy of Mindray)

In 2017, the European Union (EU) introduced its newest Medical Device Regulation (MDR) to replace the existing Medical Device Directive (MDD). The MDR establishes a more stringent regulatory framework to govern the production and distribution of medical devices, requiring companies to advance and demonstrate greater product development and quality control capacities, with a transition period currently extending to 2027 and 2028, depending on risk classification. Under the European Union's newest MDR, defibrillators, as a high-energy life-support device, have been up-classified to the highest Class III for direct impact on patients’ internal organs and systems, and thereby a potential risk of further injury or even life threat. This classification requires manufacturers to provide more details of technical documents and clinical evidence, and to go through a conformity assessment conducted by a notified body.

Mindray (Shenzhen, China) has received the CE marking for its defibrillation product family under the EU’s MDR. With the new rule tightening the controls for defibrillation devices, Mindray has become among the first manufacturers in the world to earn MDR accreditation for product quality and effectiveness. Four of Mindray’s BeneHeart series defibrillators have become among the first to earn certification under the EU’s tightened MDR controls. This includes three new models that will soon be launched, as well as the company’s already widely-used flagship BeneHeart D6.

Mindray’s BeneHeart series defibrillators, which have earned accreditation for quality and effectiveness, use mature 360J biphasic technology with automatic impedance compensation, which can significantly reduce the amount of current passing through the heart during defibrillation and lower the risk of potential damage to myocardial tissue and the patient’s skin. Automatic impedance compensation functionality can also measure impedance of the patient and automatically adjust discharge voltage and discharge time. Mindray’s newly-certified defibrillators reduce the entire defibrillation process to 7.5 seconds. Mindray has now received MDR certification for almost all its flagship products, including patient monitors, ventilators, electrocardiographs, and infusion pumps, reinforcing the company’s ability to continue to provide innovative and high-value solutions to healthcare professionals.

“These certifications are sound validation of our long-term efforts to secure robust product development and quality management system. Mindray’s product development is fully compliant with the ISO 13485 Medical Devices Quality Management System,” said Shao Lingyun, General Manager of Mindray Central R&D Management. “We have invested in the design and development and clinical validation of our products from the very beginning and worked closely with international healthcare professionals and institutions to continually improve our product effectiveness and secure a high and stable level of product quality. It is through these incremental efforts that Mindray is confident in bringing about meaningful changes to the healthcare practices and outcomes.”

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