Inspire Therapy Meets New EU Medical Device Standards

Summary: Inspire Medical Systems has achieved CE mark certification under the European Union’s updated Medical Device Regulation (EU MDR) for its sleep apnea treatment, Inspire therapy. This certification ensures compliance with the EU’s more stringent requirements, allowing Inspire to continue providing its product in several countries. The new certification also includes approvals for full-body MRI scans and the use of silicone-insulated leads.

Key Takeaways:

• EU MDR Certification: Inspire Medical Systems’ sleep apnea treatment has received CE mark certification under the EU’s updated and more stringent Medical Device Regulation, ensuring compliance with new regulatory standards.
• Expanded Capabilities: The certification now allows Inspire therapy patients in the EU to undergo full-body MRI scans in the 1.5T MRI environment, provided they follow the specified guidelines.
• Product Enhancements: The current version of Inspire therapy, featuring leads with silicone insulation, has also received CE mark certification under the new EU MDR.

Inspire Medical Systems, a medical technology company focused on the development of solutions for patients with obstructive sleep apnea (OSA), announced CE mark certification under the European Union’s Medical Device Regulation (EU MDR) 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,” says Tim Herbert, chairman and president of Inspire, in a release. “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 (ie, EU MDR) for the certification of medical devices in the EU. As a result, the 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,” says Andreas Henke, executive vice president, and managing director of Europe, in a release.

MRI Compatibility, Insulation Features Now CE Marked 

There are two changes to Inspire therapy that are now CE marked under the EU MDR that were not previously certified under the Active Implantable Medical Device Directive. First, Inspire patients in the EU may now undergo full-body MRI scans in the 1.5T MRI environment, provided the conditions specified in the Inspire MRI guidelines manual are met. 

Additionally, the current version of Inspire therapy’s leads with silicone insulation are now CE marked in the EU.