Mindray secures EU MDR certification for three core surgical devices as TÜV Rheinland strengthens strategic partnership in Nanjing

Mindray secures EU MDR certification for three core surgical devices as TÜV Rheinland strengthens strategic partnership in Nanjing

(IN BRIEF) TÜV Rheinland Greater China has issued EU MDR Notified Body Certificates to three key Mindray surgical devices—the Articulating Endoscopic Linear Cutter and Reloads, Polymer Ligation Clip and Reusable Electrode Surgical Instruments—during a July 11, 2025 ceremony in Nanjing. The certification confirms Mindray’s compliance with EU performance, safety, clinical and post-market requirements and marks a milestone in the company’s international expansion. Executives from both organizations, including TÜV Rheinland’s Wendy Geng and Mindray’s Zuo Pengfei and Shao Lingyun, highlighted the professionalism of the collaboration and the strategic importance of the approval for Mindray’s minimally invasive surgery portfolio. TÜV Rheinland, a Notified Body for MDR and IVDR, will continue to support manufacturers with services ranging from conformity assessments and ISO 13485/MDSAP certifications to INMETRO approvals and device testing, helping accelerate global market entry and strengthen the competitiveness of Chinese medical technology firms.

(PRESS RELEASE) COLOGNE, 22-Jul-2025 — /EuropaWire/ — TÜV Rheinland Greater China, the international testing, inspection and certification leader, has granted EU Medical Device Regulation (Regulation (EU) 2017/745, MDR) Notified Body Certificates to three flagship surgical products from Hangzhou Mindray Medical Technology Co., Ltd. (Mindray): the Articulating Endoscopic Linear Cutter and Reloads, Polymer Ligation Clip, and Reusable Electrode Surgical Instruments. The handover ceremony in Nanjing marks a pivotal moment in Mindray’s globalization roadmap, confirming full compliance with stringent EU regulatory and technical benchmarks and deepening the strategic collaboration between the two organizations.

Senior representatives from both sides attended the event, including Wendy Geng, Senior Vice President, TÜV Rheinland Greater China Medical; Tony Chen, Local Field Manager, TÜV Rheinland Shanghai Medical; Zhang Haifeng, General Manager, TÜV Rheinland Nanjing; and from Mindray, Zuo Pengfei, General Manager of the Surgical Product Line; Shao Lingyun, General Manager of the Central R&D Management Department; Wang Wenlong, Director of Surgical Product Development; and Wang Xinbing, Deputy Director of Regulatory Affairs.

Congratulating Mindray, Wendy Geng noted that achieving MDR certification across three core devices “showcases Mindray’s excellence in technical innovation, quality systems and global compliance.” She added that TÜV Rheinland is eager to extend the partnership to seize new opportunities and push forward high-quality, innovative development across the medical device landscape.

Echoing that sentiment, Zuo Pengfei praised the TÜV Rheinland team’s professionalism and efficiency throughout the project, emphasizing that the certificates validate Mindray’s dedication to rigorous R&D and manufacturing standards. “This milestone is central to our internationalization journey,” he said. “We’re committed to working even more closely with TÜV Rheinland to deliver safer, more reliable surgical solutions to patients worldwide.”

Reflecting on the long-standing relationship, Shao Lingyun underscored that certifying the Articulating Endoscopic Linear Cutter and Reloads, Polymer Ligation Clip and Reusable Electrode Surgical Instruments under the MDR is a watershed for Mindray’s minimally invasive surgical product line. “It signals a fresh starting point for wider, deeper cooperation with TÜV Rheinland,” Shao said, expressing gratitude for the support and outlining ambitions to elevate Chinese medical devices on the global stage.

Complying with the MDR is non-negotiable for EU market entry and entails rigorous demands on product performance and safety, pre‑market clinical evaluation, robust clinical data generation, and continual post-market surveillance. Mindray’s success across all three devices demonstrates strong competencies in design, development, manufacturing and quality assurance, fully meeting the EU’s bar for access.

Leveraging extensive global expertise in medical device certification, TÜV Rheinland provides comprehensive market-access services. Its international specialist teams translate regulatory requirements into practical pathways, combining precise standards interpretation with efficient auditing to accelerate time-to-market and sharpen the competitiveness of Chinese manufacturers abroad. As a Notified Body for both the MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR), TÜV Rheinland’s offerings include MDR/IVDR conformity assessments, ISO 13485 and Medical Device Single Audit Program (MDSAP) certifications, Brazilian INMETRO approvals, and a broad suite of testing services for medical devices.

Media Contact:

Simon Hung
Tel: 852 2192 1948
Email: Simon.Hung@tuv.com

SOURCE: TÜV Rheinland