Practical implication
Manufacturers must familiarize themselves with the new procedure, including creating an EMA account and understanding the timelines for submitting the required briefing documents according to the established timetable for 2025 and 2026.
The EMA has issued new guidance for manufacturers regarding the process to request scientific advice for high-risk medical devices, effective from February 2025. This includes detailed steps for creating an EMA account, submitting a 'letter of interest', and timelines for briefing documents.
What changed: The EMA introduced formal guidance that outlines how EU-based manufacturers can request scientific advice via expert panels for high-risk medical devices.
Why it matters: This guidance streamlines the process for manufacturers seeking clinical advice, improving support and regulatory engagement for high-risk medical devices, thereby enhancing patient safety and device efficacy.
Practical implication: Manufacturers must familiarize themselves with the new procedure, including creating an EMA account and understanding the timelines for submitting the required briefing documents according to the established timetable for 2025 and 2026.
View original source
- Source: EMA - What's new
- Published at source: 2026-09-01T07:00:00.000Z
- Discovered by monitor: 2026-09-01T21:48:03.634Z
Published from the regulator source ingestion pipeline after PV impact triage.
