The IVDR compliance deadline is here! If you’re a manufacturer, it’s crucial to ensure your Quality Management System (QMS) is compliant and your IVDR application is submitted to a Notified Body. For Class D IVD manufacturers, this includes submitting the application and getting a written agreement with a Notified Body by September 26, 2025. Ensuring your Technical Documentation is in order is critical for keeping your legacy devices on the market under the new regulations.
Learn more about IVDR compliance
Visit our website to discover how GBA Key2Compliance can support you in staying compliant. We offer comprehensive services for both new IVDs and legacy devices, providing expert guidance on key changes, timelines, and compliance strategies under the new IVDR requirements.
Explore our services here.
Webinar: IVDR Compliance – The Next Steps
Join us on May 27, 2025, from 10:30 to 11:15 CET, for a webinar with our expert Åse Ek. She will guide you through how ISO 13485 supports IVDR compliance and the additional steps your QMS needs to fully meet regulatory requirements.
Need help with IVDR compliance?
Our team is here to assist you every step of the way. Contact us today for a consultation and let’s ensure your path to compliance is smooth and successful!