MDR certification achieved - a major milestone for CarpoNovum
- lisa60462
- Nov 17, 2025
- 2 min read
We are proud to announce that CarpoNovum’s C-REX product family has achieved CE marking under the EU Medical Device Regulation (MDR) – an important milestone on our journey to improving outcomes in colorectal surgery.
C-REXÂ is an innovative family of surgical devices designed to facilitate colorectal adaptive anastomoses.
Colorectal cancer is one of the most common cancers globally, and more than 1 million individuals worldwide undergo colorectal surgery every year. Yet postoperative complications such as leakage, stricture, and disturbed bowel function remain a major challenge. C-REX aims to address this unmet clinical need. C-REX features a unique anastomotic ring that is naturally expelled through the anal canal, leaving no foreign material inside the intestine that might interfere with the healing.
The CE marking under MDR confirms the safety and clinical performance of C-REX, following a comprehensive review by a notified body, paving the way for future commercialization across Europe.
“We are proud of reaching this major regulatory milestone. It has been a long and demanding journey, made possible by the strong innovation by founder Anders Grönberg, hard work of our dedicated team and constructive dialogue with our Notified Body. The MDR approval for C-REX secures future-proof access to the European market and strengthens our position in future regulatory processes, including those in North America,“ says Otto Drakenberg, Chairman of the Board, CarpoNovum AB.
CarpoNovum is currently engaged in on-going post-market clinical trials at several renowned sites in Europe for preparing hospitals and surgeons to adopt C-REX as a viable alternative for appropriate patients in a holistic and tailored surgical strategy.
We are deeply grateful to our clinical partners and trial sites across Europe who share our vision to enhance colorectal surgery for better patient outcomes!