Mindray becomes the first China medical device manufacturer that received MDR certificate

Mindray Medical (SZ.300760)today announced that its Resona 7 (Ultrasound Diagnostic System) has received CE certificate, which makes Mindray the first China medical device manufacturer that received European Medical Device Regulation (MDR (EU) 2017/745) certificate, issued by TÜV SÜD.

As the “VISA” to enter the EU (European Union) market, CE certificate is the critical requirement for all the product which can be sold in EU. The MDR (Medical Device Regulation) will replace current MDD (Medical Device Directive), with the aim to establish a modernized and more robust EU legislative framework to ensure better protection of public health and patient safety.

The regulation will be fully applicable by May 2020. As a medical device manufacturer, since established, Mindray has consistently invested in R&D as well as quality and regulatory compliance. Over the past 12 months, Mindray has developed company-wide cross-function project team to manage the timely transition of all its devices as well as its quality management system toward this new regulation.

 “The MDR brings a significant change to the regulatory framework for medical devices in Europe that emphasizes quality and safety,” said He Xujin, General Manager of Medical Imaging Business Unit at Mindray Medical. “Mindray has been providing world-class medical device to European Market more than 20 years, and Europe is our second largest overseas market. Our QA&RA team have been preparing for the transition since the MDR became effective, and now, we are very proud to be the first China company to receive the certificate.”

Obtaining the first MDR certificate for Ultrasound Diagnostic System is just the first step amid a series of important steps towards MDR certification of Mindray’s entire product portfolio. Mr. He commented: “With this pivotal stage accomplished, we have set a precedent for the future.”