What is the webinar about?

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.

Who should attend?

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.

What will participants gain?

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.

Speakers

 
Richard
Holborow
Global Head, Clinical Compliance, BSI
Enter your first name
Enter your last name
Enter your job title
Enter your company name
Enter your phone number
Select your country
Enter your postcode
Let us know if there any other products or services you are interested in, if you have any other questions, or if there’s any additional information you’d like us to know before we contact you.
Please read the BSI Privacy Notice for further information regarding your rights.