Episode description
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:
- Have you had to restrict or reduce the indications for your device as part of the transition to MDR 2017/745?
- Are you struggling to define your indications and contra-indications for your device?
- Have you started to see examples of off-label use cropping up as your PMCF data comes back in?
- Are you trying to expand your indications using real-world data from post-market surveillance?
- Are you struggling to handle instances of off-label use within your risk management process?
Our panelists provided valuable insights into these questions and more from the audience! We hope you'll give this show a listen.
Panelists:
- Dr. Tom Melvin, Associate Professor of Medical Device Regulatory Affairs - Trinity College Dublin (former HPRA)
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation - RQM+
- Dr. Sally Sennitt, Medical Director, Intelligence and Innovation - RQM+
- Ed Ball, Manager, Intelligence and Strategic Execution - RQM+