 |
ShanghaiApril 29, 2026 /PRNewswire/ — Recently, TÜV Rheinland Greater China, an internationally independent third-party testing, inspection, and certification organization, issued a notified body certificate under the EU Medical Device Regulation (Regulation (EU) 2017/745, referred to as MDR) for Shanghai United Imaging Medical Technology Co., Ltd.’s (referred to as United Imaging) CT-guided medical linear accelerator system (product model: uLinac EternaTx). This is the first MDR certificate for radiotherapy equipment issued by TÜV Rheinland in Greater China, marking a significant step forward in the compliance process of China’s high-end medical equipment in the EU market.
The certified United Imaging CT-guided medical linear accelerator system (also known as radiotherapy equipment) is primarily used for tumor radiation therapy. This type of equipment features high technological integration, a relatively complex structure, and directly interacts with the human body for therapeutic intervention. The EU Medical Device Regulation imposes stricter review requirements for such medical devices, including clinical evaluation, post-market surveillance, and quality system compliance, making it more challenging than general diagnostic equipment.
In this project, TÜV Rheinland leveraged its mature localized service advantages to efficiently coordinate progress and key milestones. Local technical experts deeply participated in technical document reviews and compliance audits, while collaborating cross-regionally with experts from the German headquarters to ensure smooth project advancement under a complex regulatory environment. Ultimately, United Imaging successfully passed TÜV Rheinland’s rigorous review and obtained the MDR notified body certificate.
The successful completion of the MDR certification for United Imaging’s uLinac EternaTx medical linear accelerator system not only demonstrates continuous breakthroughs in the R&D capabilities and compliance levels of China’s high-end medical equipment but also sets a new benchmark for Chinese-made radiotherapy equipment entering the EU market.
As a notified body for MDR and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR), TÜV Rheinland possesses deep technical expertise and a global network of experts in the medical device field, providing comprehensive support to medical device companies. Its services cover MDR/IVDR conformity assessment, ISO 13485 system certification, Medical Device Single Audit Program (MDSAP) system certification, Brazil INMETRO certification, as well as medical device testing services including safety, electromagnetic compatibility, performance, usability, and cybersecurity. Additionally, it offers full-dimensional compliance technical support and solutions in conjunction with the EU Artificial Intelligence Act (EU AI Act). In the future, TÜV Rheinland will continue to leverage its extensive industry experience and technical advantages to provide professional and efficient support for the international development of Chinese medical device companies, helping manufacturers quickly and compliantly enter overseas markets.
