Inspire Medical Systems announced CE mark certification under the European Union’s Medical Device Regulation, EU MDR 2017/745, for Inspire therapy. “Inspire has a long history of compliance to the European Union’s quality system and CE mark requirements, with uninterrupted CE mark approval since 2010,” said Tim Herbert, Chairman and President of Inspire. “The Inspire team has worked diligently with our notified body in Europe to complete the review process, which included obtaining temporary approval through derogation authorization to continue to deliver Inspire product in several countries.”
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