EC Medical Devices · September 12, 2025

Update - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - September 2025

EC updated the manual on borderline and classification for medical devices and IVDs under MDR and IVDR.

High impact Medical Devices Digital Health & AI EU-wide medical-devicesclassificationivdsamd

News announcement 12 September 2025 Update - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - September 2025 1 min read

Read the official source ↗

Published by EC Medical Devices. HealthSignal links to the original document; the summary above is extracted from the source text.