Team-NB Notified Bodies Urge Manufacturers to Apply for IVDR Certification

In a press release published in October 2023, Team-NB, the European Association of Medical Devices Notified Bodies, called on manufacturers to apply for IVDR certification as soon as possible, especially for high-risk IVD medical devices.

For Class D devices, Team-NB strongly recommends submitting applications by the end of 2023 to allow for timely technical documentation assessments.

This call to action comes as the deadline for compliance with the IVDR draws near. The IVDR is a new European regulation that sets higher standards for the safety and performance of in vitro diagnostic (IVD) medical devices.

To learn more about the IVDR transition and how to apply for certification, visit the Team-NB website.

🔗 Original Document:  https://www.team-nb.org/wp-content/uploads/2023/10/Team-NB-PressRelease-Capacity-NotifiedBodies-during-transition-IVDR-MDR-October2023.pdf