Off-label? Don't panic: A strategic approach to real-world data
Real-world data (RWD) and real-world evidence (RWE) are rapidly reshaping clinical and regulatory strategies under EU MDR and beyond. Yet despite growing recognition of their value, many manufacturers still struggle to collect, structure, and leverage RWD effectively; whether that means selecting the right collection approach, meeting notified body expectations, or knowing how to act on unexpected findings such as off-label use.
When approached strategically, RWD can help confirm long-term safety and performance, strengthen your clinical evidence base, support label expansions, and identify unmet clinical needs. The challenge lies in building a framework that is both methodologically robust and proportionate to your device and regulatory context.
This webcast features expert presenters Edward Nobrega, Principal Clinical Evaluation Scientist at Boston Scientific, Breda Kearney, Clinical Regulatory Lead at BSI, and Marcus Torr, Head of Post Market Surveys at Purdie Pascoe.
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