Shanghai, China, 03 July 2023 - On June 19th, Shanghai Microport MedBot (Group) Co., Ltd. (hereinafter referred to as "MicroPort® MedBot™") successfully obtained CE certification from the European Union for its DFVision™ 3D Electronic Laparoscope (hereinafter referred to as "DFVision™"). With this achievement, DFVision™ becomes the first Chinese-developed 3D electronic laparoscope that has obtained both NMPA approval and CE certification in the European Union.
The certification process completed by DFVision™ is in accordance with the European Medical Device Regulation (Regulation [EU] 2017/745, referred to as MDR). MDR is a new regulation in the European Union for the medical device field. Compared to the previous Medical Device Directive (MDD), MDR focuses more on the device's clinical performance, better traceability of medical devices, and higher patient transparency. It imposes stricter requirements for market access of medical devices in the European Union and strengthens the requirements for manufacturers, importers, distributors, and notified bodies.
DFVision™ is used for intraoperative exploration and imaging in endoscopic surgery, allowing for observation, diagnosis, photography, or treatment of organs in the abdominal and thoracic cavities. It features high-quality optical specifications, a lighter body, and compatibility with endoscopic surgical robot platforms. High-resolution imaging objectives and an electronic laparoscope structure achieve dual-channel full HD presentation, providing surgeons with a three-dimensional sense of the surgical field of view and depth perception for surgical operations. It meets the clinical demand for high precision and anatomical detail, playing an important role in precise dissection, suturing, and knotting during surgery. It can reduce surgical time, decrease surgical errors, improve surgical quality, and enhance surgical efficiency. It breaks through traditional two-dimensional laparoscopic surgery's limitations and applies to various departments such as urology, general surgery, thoracic surgery, and gynecology.
Mr. Liu Yu, Executive Vice President and Chief Commercial Officer of MicroPort® MedBot™, said, "Compared to traditional laparoscopy, DFVision™ is closer to and meets the surgical needs of doctors. After obtaining NMPA approval, obtaining CE certification from the European Union reaffirms the product’s safety. In the future, MicroPort® MedBot™ will serve the medical community through clinical applications, allowing domestically advanced medical devices to maximize their value in clinical transformation and fulfill the initial mission of 'Make Surgery Easier, Safer and Less Invasive.'"