Bluesail Surgical Smart Powered Endocutter has successfully obtained the approval of EU CE MDR

Recently, Bluesail Surgical Smart Powered Endocutter Astrolux® and Siderlux® have successfully passed the EU CE MDR certification, and successfully obtained the certificates issued by DEKRA, the notified body authorised by the EU Medical Device Regulation (2017/745, MDR).

This groundbreaking approval signifies that Bluesail Surgical has further expanded the market accessibility of the powered endocutter besides the manual endocutter in the EU market of 27 countries, and has become one of the first manufacturers of national brands to obtain the MDR compliance certification. Moreover, in addition to the Manual Endocutter, the approval of the Novel and innovative Smart Powered Endocutter will help Bluesail Surgical to effectively enhance the competitiveness of its products in the international market.

MDR compliance certification is a new access condition for medical device products to enter the EU market. From Directive to Regulation, the EU has raised the threshold of access to medical device products. Compared with the old Directive MDD, MDR has stronger regulation and more difficult conformity assessment, which puts forward higher requirements in terms of product risk management, performance and safety standards, pre-market clinical evaluation as well as post-market vigilance and supervision of the products, bringing new challenges to national enterprises planning to enter the EU. With a focus on better clinical performance, better traceability of medical devices and more transparency for patients, access to the European market for medical devices has become more stringent, with expanded and strengthened requirements for manufacturers, importers, distributors and notified bodies, with the aim of ensuring better protection of public health and patient safety.

The approved Powered Endocutters can be used widely for cutting, dissecting and anastomosing tissues such as lungs, stomach, intestines and other tissues in open or laparoscopic surgeries. The first generation of the previously approved products has already served more than 100,000 patients in Europe. The two Smart Powered Endocutters were assessed by DEKRA's global audit team for their excellent clinical data integrity, product quality and management system compliance with the technical requirements of the MDR regulation.

This time, Bluesail Surgical's two Smart Powered Endocutter successfully passed the MDR conformity assessment, which is a high degree of recognition of Bluesail Surgical's powered endocutter series for product quality and safety, technical innovation, etc., It also fulfils the promise of "Bluesail not only belongs to China, but also to the world". Bluesail Surgical is firmly committed to contributing to the development of the global medical field through the continuous introduction and innovation of international advanced medical technologies. In terms of surgical therapies, Bluesail Surgical is committed to promoting the global upgrade of surgical technology towards more precise, minimally invasive and non-invasive, with fewer complications and better prognosis. This will not only help to improve the level of surgical treatment in China, but will also benefit global patients and contribute to the health of the world's people.