Webinar 1: Breaking through MDCG 2025-9 - Leading the Path with Innovation
9 June - 15:00 BST
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 an 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.
Webinar 2: Structured Dialogue - Achieving Predictable Reviews with BSI
16 June - 16:00 BST
This webinar shows manufacturers how to work more effectively with BSI by getting the fundamentals right early. We’ll start with onboarding – aligning on contacts, expectations, and readiness so your review begins with fewer surprises. Then we’ll demystify Structured Dialogue and show how to use it to resolve ambiguity upfront, reduce rounds of review questions, and how to protect your conformity assessment timelines.
Attendees will leave with a clear, practical playbook for working with BSI from day one, including how to align goals for your regulatory pathway, what to bring to early conversations, and how to avoid common missteps that create downstream delays. You’ll also learn how to use Structured Dialogue effectively and confidently while resolving any ambiguity upfront and reduce avoidable review cycles to protect your submission plans and certification timelines.
Webinar 3: Certify with Confidence & Clarity - Maximize Your Review, Minimize Your Timeline
23 June - 16:00 BST
This webinar focuses on clarity for your path forward to certification through communication. We will provide examples into how manufacturers can work smarter through the review process by optimizing structured dialogue and streamlining dedicated interactive reviews to keep reviews moving.
Participants will learn how fast-track review models streamline the process and provide insights into how active BSI Notified Body interactions work seamlessly throughout the review. Participants will also leave with a clear understanding on how to address Notified Body expectations and prepare well-supported responses that help close the review loop more efficiently.
