Practical implication
Manufacturers must now incorporate expert panel feedback into their conformity assessment processes, ensuring timely integration of provided expert advice into their evaluation and regulatory submissions.
The EMA's pilot programme on breakthrough medical devices (BtX) establishes a structured process for manufacturers and notified bodies to request expert panel support, aimed at streamlining the regulatory pathway for innovative medical devices.
What changed: The EMA has launched a pilot programme that allows manufacturers and notified bodies to request advice from expert panels regarding breakthrough medical devices, following the MDCG 2025-9 guidance.
Why it matters: This pilot programme enhances the regulatory support for breakthrough medical devices, encouraging innovation while ensuring compliance with safety and efficacy standards.
Practical implication: Manufacturers must now incorporate expert panel feedback into their conformity assessment processes, ensuring timely integration of provided expert advice into their evaluation and regulatory submissions.
View original source
- Source: EMA - What's new
- Published at source: 2026-09-01T07:00:00.000Z
- Discovered by monitor: 2026-09-01T21:48:03.629Z
Published from the regulator source ingestion pipeline after PV impact triage.
