This show was recorded 25 May 2023 and can be viewed on our website ⁠⁠here⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠Knowledge Center⁠⁠⁠. Thank you for listening!

This panel discussion is all about navigating off-label use and implementing strategies to improve medical device safety. As we all know, ensuring the safety and efficacy of medical devices is critical to protecting patients and minimizing risks to healthcare providers. However, one of the key challenges manufacturers face is how to identify and handle off-label use, especially with the transition to MDR 2017/745.

During the discussion, our experts in device development, regulatory compliance and clinical evaluation shared insights on how to manage off-label use, reduce indications, define indications and contra-indications, as well expand indications using real-world data from post-market surveillance. We dove into the complexities of post-market surveillance and the importance of PMCF data in identifying off-label use. We also explored strategies for optimizing regulatory efforts while maintaining patient safety.

Key questions for our audience include:

Our panelists provided valuable insights into these questions and more from the audience! We hope you'll give this show a listen.

Panelists: