The Global Shift in Real-World Evidence: Insights from MedTech Industry Leaders

Wednesday, 11 February 2026
10:00 EST | 15:00 GMT | 16:00 CET

Real-World Evidence (RWE) is playing an increasingly important role in global MedTech regulatory decision-making, supporting evidence generation across the product lifecycle, from pre-market submissions to post-market surveillance.

Recent regulatory developments underline this shift, including the FDA’s final guidance on the use of RWE for medical device decision-making and the European Commission’s proposal to simplify MDR and IVDR, both of which have important implications for how real-world data (RWD) is generated and assessed.

This 1-hour live webinar brings together industry experts: Richard Holborow, Head of Clinical Compliance from Notified Body BSI, Cori Maegley, Vice President, Partnerships Management, MDIC's NEST Initiative, Marcus Torr, Head of Post Market Surveys, Purdie Pascoe and Amelia Hufford, SVP, Clinical and Regulatory Science from 3Aware. They will unpack what these changes mean in practice and how MedTech manufacturers can build effective, compliant RWE strategies.

Key takeaways:

• Navigate FDA expectations for RWD, including its use in pre-market decision-making

• Apply RWD under EU MDR from a Notified Body perspective, with a focus on PMCF and potential impacts of MDR/IVDR

• Use Post Market Surveys as a source of regulatory-grade RWD, supported by real-world case studies

• Derive actionable insights from patient-level clinical RWD tied to specific devices

A live Q&A will follow the presentation. Please submit your questions when registering or during the event.

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