Breakthrough Device Designation in the EU: A New Regulatory & Market Access Pathway

The European Commission’s Breakthrough Device pathway is one of the most anticipated regulatory developments in MedTech — offering earlier scientific guidance, accelerated interactions, and the potential for more predictable market access for high-impact, high-innovation medical technologies.

In this expert panel session, regulators, notified body leaders, and industry experts break down what we know now about the EU Breakthrough Pathway, how it compares to the U.S. FDA’s program, and what manufacturers should begin preparing for ahead of formal implementation.

This is one of the first public discussions combining regulator, notified body, and industry perspectives on this transformative new pathway.

⭐ You’ll Learn
• The goals and structure of the EU Breakthrough Device Pathway.
• How HPRA is preparing for breakthrough evaluations.
• What Notified Bodies expect for early scientific interactions.
• How clinical evidence requirements may differ from MDR.
• How global manufacturers should compare EU vs. U.S. breakthrough strategies.
• Practical steps to prepare your documentation, evidence, and eligibility rationale.
• Open Q&A with regulators, NBs, and industry leaders.

🎙️ Subject Matter Experts
✅ Dr. Donal O’Connor
Clinical Manager, Medical Devices
Health Products Regulatory Authority (HPRA), Ireland

✅ Matthias Fink
Senior Clinical Consultant
AKRA TEAM GmbH, Germany

✅ Dan Kosednar
Vice President, Regulatory Affairs
HistoSonics, Inc. (USA)

✅ Richard Holborow
Head of Clinical Compliance
BSI Group (UK)

⏱️ Chapters
(00:00) – Welcome & introductions
(02:10) – Why an EU Breakthrough Device pathway now?
(06:00) – Overview of the proposed EU framework
(10:30) – HPRA perspective on breakthrough designation
(16:00) – AKRA TEAM view: clinical & regulatory implications
(21:00) – Industry perspective: opportunities & challenges (HistoSonics)
(27:00) – Notified Body expectations (BSI)
(33:00) – Comparing EU and U.S. FDA Breakthrough programs
(39:00) – Clinical evidence, study design & real-world data
(45:00) – Market access & reimbursement signals for breakthrough devices
(50:00) – How to prepare a strong EU breakthrough application
(55:00) – Audience Q&A
(59:00) – Key takeaways & closing remarks