Mindray amongst world’s first to receive EU Medical Device Regulation Certification

As the new rule tightened the controls for defibrillation devices, Mindray has become one of the first manufacturers in the world to achieve MDR accreditation for the products’ quality and effectiveness.

Sudden cardiac death and arrhythmia account for up to 20% of all deaths throughout the world, according to academic research. Defibrillators deliver an electrical shock to restore a patient’s normal cardiac rhythm and are a key medical equipment to sustain the patient’s life.

Introduced in 2017 to replace the existing Medical Device Directive (MDD), the MDR established 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.

Mindray has now received MDR certification of 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.

Ireland Defibrillator for Sports Club