05/28/2026
Breakthrough Devices under EU MDR & IVDR: Clarity is finally coming.
MDCG 2025-9 has created a new Breakthrough Device (BtX) designation pathway and manufacturers are unsure what it means in practice.
In this upcoming webinar, BSI experts cut through the complexity and walk through the BtX pathway step‑by‑step:
- What qualifies as a BtX device?
- How do EU Expert Panels actually assess applications?
- What clinical and post‑market obligations come with designation?
Who should attend?
Medical device professionals across Regulatory, Clinical, R&D, Quality, and Leadership, especially anyone working on novel or high‑risk technologies.
📅 June 9, 2026 | 10:00 AM ET | 45 mins + 15 mins Q&A
Register here: https://bit.ly/4wWrFFU