WEBINAR 1 – Breaking through MDCG 2025-9- Leading the Path with Innovation

This webinar offers a clear, practical overview of the Breakthrough Device (BtX) designation pathway under EU MDR and EU IVDR, as clarified in MDCG 2025‑9. Learn how to cut through complexity with Richard Holborow, BSI’s Head of Clinical Compliance and how EU expert panels assess applications and clinical evidence.

The session also marks the launch of BSI’s dedicated BtX review service, outlining how manufacturers can engage through Dedicated Interactive Reviews and Structured Dialogue to support designation and conformity assessment.

Participants will gain a practical understanding of what BtX designation means in practice, from eligibility assessment to clinical and post‑market expectations. The webinar provides insight into Expert Panel evaluations, certificates with conditions, and how to work with BSI’s new BtX service to align clinical and regulatory pathways with MDCG expectations from the earliest stages of device development.

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This is the first of three‑part webinar series designed to help medical device manufacturers navigate EU MDR & IVDR with confidence and predictability. Across the series, our experts unpack how clearer alignment and early collaboration with BSI support the Breakthrough Device (BtX) pathway, effective use of Structured Dialogue, and fast‑track, interactive review models that reduce rework and protect timelines.