GI Dynamics (ASX:GID) said yesterday that it tapped a new notified body in Europe, nearly a year after losing CE Mark approval there, as it eyes a market return for its EndoBarrier device by the end of next year.
In the European Union, notified bodies are used as part of the regulatory system to assess product conformity. The erstwhile notified body for Boston-based GI Dynamics, SGS United Kingdom, last November took the company by surprise when it withdrew CE Mark certification for the EndoBarrier obesity and diabetes treatment.
Yesterday GID said it named Intertek to replace SGS and review the technical file and clinical data for EndoBarrier and ensure that the company’s quality management system is compliant with international requirements.
“Initiating work with Intertek represents a significant step towards achieving an EndoBarrier CE Mark and brings us closer to commercialization in Europe and the Middle East,” president & CEO Scott Schorer said in prepared remarks. “This is an important step as we continue to develop EndoBarrier as the lead implant for the treatment of Type 2 diabetes and obesity.”
GI Dynamics said it plans to win back CE Mark approval for the EndoBarrier during the second half of 2019.