Description Join us for an overview of the Breakthrough Device Pathway in Europe that was launched in 2025 and will come into effect from the 1st April 2026. Gain an understanding of what types of devices can qualify, how manufacturers can obtain such a Breakthrough status from the European Expert Panels and how notified bodies will conduct a conformity assessment. We will also consider what post market requirements and commitments will be needed for breakthrough devices.
Learning Objectives:
Understand the process of obtaining breakthrough designation in the EU
Understand what a conformity assessment looks like for a breakthrough device
Understand the post market commitments for a breakthrough device.
.png)
