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Webinar
Medical Devices

Breaking through MDCG2025-09 - Leading the Path with Innovation

MDCG 2025-9 has created a new Breakthrough Device (BtX) designation pathway and manufacturers are unsure what it means in practice.

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Breakthrough Devices under EU MDR & IVDR: clarity is finally coming

Our BSI experts cut through the complexity and walk through the BtX pathway step‑by‑step.

Practical insight into how EU Expert Panels evaluate BtX applications.
How manufacturers can engage with the BtX process through dedicated interactive reviews.
How to align clinical and regulatory strategy to support BtX designation.
Clear understanding of what BtX designation means in practice

Speaker

Hear from the expert in this webinar

Speaker

Richard Holborow

Global Head, Clinical Compliance, BSI

BSI Insights Series: Better Together

Additional resources to support you

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.
This webinar is open to anyone working at a medical device company with an interest in the Breakthrough Device pathway – regardless of function or seniority.

This includes:

Professionals in Regulatory Affairs.

Clinical and Medical Affairs.

R&D.

Quality.

Senior Leadership.

It’s particularly relevant for those involved in or responsible for innovation strategy, clinical evidence planning, regulatory submissions, or product development for novel or high-risk devices where BtX designation may be applicable.
Participants will leave with a clear understanding of what BtX designation means in practice – from eligibility assessment through to the clinical evidence expectations and post-market obligations that come with it.

They will gain:

Practical insight into how EU Expert Panels evaluate BtX applications, and what certificates issued with conditions require of manufacturers.

How manufacturers can engage with the BtX process through dedicated interactive reviews and structured dialogue at different stages, in line with MDCG expectations.

How to align clinical and regulatory strategy to support both BtX designation and subsequent conformity assessment.
This webinar shows manufacturers how to work more effectively with BSI by getting the fundamentals right early. We’ll start with onboarding – aligning on conformity assessment stakeholders, 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.

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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, streamlining dedicated interactive reviews to keep reviews moving.

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A service specifically designed to support the timely conformity assessment of breakthrough medical technologies.

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