Inspire Medical Systems Announces CE Mark Certification Under European Union's Medical Device Regulation For Inspire Therapy

"Inspire has a long history of compliance to the European Union's (EU) 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."

"In 2017 the European Parliament enacted a new regulatory framework (i.e., EU MDR 2017/745) for the certification of medical devices in the EU. As a result, the entire medical device industry must repeat the process for both design and quality system certification to the new, more stringent, requirements. The scale of this transition to a new regulatory framework has proven to be a challenge for medical device manufacturers and the notified bodies who certify them. Given that, Inspire is pleased to reach this critical milestone," said Andreas Henke, Executive Vice President, Managing Director Europe.