Mindray Achieves EU MDR Certification for Three Surgical Products with Support from TÜV Rheinland

Mindray Achieves EU MDR Certification for Three Surgical Products with Support from TÜV Rheinland

(IN BRIEF) Mindray has received EU MDR Notified Body Certificates for three core surgical products—Articulating Endoscopic Linear Cutter and Reloads, Polymer Ligation Clip, and Reusable Electrode Surgical Instruments—awarded by TÜV Rheinland Greater China on July 11, 2025. This certification marks a key milestone in Mindray’s global strategy, reinforcing its compliance with stringent EU medical device regulations and its ability to deliver high-quality, innovative surgical technologies. TÜV Rheinland’s expert guidance helped facilitate the process, while both companies emphasized their commitment to deeper collaboration and advancing Chinese medical devices on the global stage. The certification affirms Mindray’s capabilities in R&D, manufacturing, and regulatory excellence, positioning it for broader international success.

(PRESS RELEASE) COLOGNE, 28-Jul-2025 — /EuropaWire/ — TÜV Rheinland Greater China has awarded EU MDR Notified Body Certificates to three key surgical products from Hangzhou Mindray Medical Technology Co., Ltd., marking a significant milestone in Mindray’s international expansion. The certification was officially granted on July 11, 2025, during a ceremony in Nanjing, underscoring Mindray’s commitment to meeting rigorous European regulatory standards and strengthening its long-standing partnership with TÜV Rheinland.

The MDR certification covers the Articulating Endoscopic Linear Cutter and Reloads, Polymer Ligation Clip, and Reusable Electrode Surgical Instruments. These products, core components of Mindray’s minimally invasive surgical portfolio, have been verified for compliance with the EU Medical Device Regulation (Regulation (EU) 2017/745). This accomplishment reflects Mindray’s robust capabilities in R&D, quality management, and global regulatory compliance.

Representatives from both organizations attended the event, including Wendy Geng, Vice President of TÜV Rheinland Greater China Medical; Tony Chen, Local Field Manager of TÜV Rheinland Shanghai Medical; Zhang Haifeng, General Manager of TÜV Rheinland Nanjing; and key Mindray leaders such as Zuo Pengfei, Shao Lingyun, Wang Wenlong, and Wang Xinbing.

Wendy Geng praised Mindray’s achievement, noting that the certification reflects the company’s strong innovation, product quality, and international competitiveness. Zuo Pengfei expressed appreciation for TÜV Rheinland’s expertise and support throughout the certification process, highlighting this accomplishment as a cornerstone of Mindray’s global strategy. Shao Lingyun emphasized the significance of this milestone for the internationalization of Mindray’s surgical technologies and expressed anticipation for further collaboration with TÜV Rheinland in the future.

Gaining MDR certification is essential for accessing the EU medical device market, which imposes rigorous standards on clinical performance, safety, data collection, and post-market surveillance. Mindray’s success in obtaining these certifications demonstrates its technical excellence and operational maturity, ensuring it can confidently expand in European and global markets.

TÜV Rheinland’s extensive global experience in medical device conformity assessment and regulatory support played a crucial role in the process. As a Notified Body under MDR and IVDR, TÜV Rheinland offers a wide range of services including ISO 13485, MDSAP, INMETRO, and device testing—facilitating international market entry for high-quality manufacturers like Mindray.

About Mindray

Founded in 1991, Mindray is a global leader in medical equipment and solutions, specializing in patient monitoring and life support, in vitro diagnostics, medical imaging, and orthopedic products, with additional expertise in veterinary medical devices. Committed to independent R&D and innovation, Mindray’s products are sold in over 190 countries and regions, earning a strong global market position through high cost-performance and technical excellence. As a leading enterprise in China’s medical device industry, Mindray has achieved notable recognition:

Ranked 25th in the 2024 Global Top 100 Medical Device Companies (third consecutive year in the top 30), with revenue of 36.726 billion RMB.

Ranked 1st overall and 1st in equipment, and 4th in consumables, in the 2024 China Medical Device R&D Strength Rankings.

Ranked 23rd in the 2024 Medtech Insight Global Top 100 Medical Device Companies.

For further information on TÜV Rheinland’s services, visit www.tuv.com. For details on Mindray, visit www.mindray.com.

Media Contact:

Menny Zhang
email: menny.zhang@tuv.com

SOURCE: TÜV Rheinland