Most recent update: Tuesday, December 12, 2017 - 16:38

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Endobarrier

CE Certificate of Conformity withdrawal notice for EndoBarrier

Withdrawal of the CE Certificate of Conformity means that the company will not be able to affix the CE Mark and sell EndoBarrier in European Union countries

GI Dynamics has received notification from its notified body SGS United Kingdom, Limited (SGS) that SGS will withdraw the CE Certificate of Conformity for EndoBarrier effective 12 November 2017. As previously announced, on 17 May 2017 the company received notification from SGS that the EndoBarrier CE Certificate of Conformity was being suspended pending resolution of non-conformances related to ISO 13485 compliance.

The company has been working diligently to address the issues raised by SGS. On Saturday 11 November 2017 (AEDT) the company received notification that SGS will withdraw the CE Certificate of Conformity issued to the company for EndoBarrier effective 12 November 2017.

The company is evaluating its options including grounds for appeal of the decision, consulting with its advisors and has initiated communications with SGS to clarify certain procedural and substantive matters relating to the notice.

Withdrawal of the CE Certificate of Conformity means that the company will not be able to affix the CE Mark and sell EndoBarrier in European Union countries until another Certificate of Conformity is issued by SGS or another notified body or any appeal is successful.

The company will provide further updates as information becomes available.

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