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EndoBarrier and CE mark

GI Dynamics prepares for EndoBarrier CE mark recertification

GI Dynamics selected Intertek for its medical device expertise and availability to support the clinical and regulatory requirements of EndoBarrier and GI Dynamics

GI Dynamics has announced the selection of Intertek as the company’s notified body to continue working toward re-attaining the CE Mark for its EndoBarrier product, an endoscopically delivered device therapy for the treatment of type 2 diabetes and obesity. GI Dynamics selected Intertek for its medical device expertise and availability to support the clinical and regulatory requirements of EndoBarrier and GI Dynamics.

As GI Dynamics notified body, Intertek will confirm that EndoBarrier conforms to the requirements of the European Medical Device Directive MDD93/42/EEC. The confirmation process includes an evaluation of the EndoBarrier technical file including relevant clinical data. Furthermore, Intertek will ensure that the GI Dynamics quality management system is compliant with ISO 13485:2016 requirements.

“Initiating work with Intertek represents a significant step towards achieving an EndoBarrier CE Mark and brings us closer to commercialisation in Europe and the Middle East,” said Scott Schorer, president and chief executive officer of GI Dynamics. “This is an important step as we continue to develop EndoBarrier as the lead implant for the treatment of type 2 diabetes and obesity.”

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