EC Medical Devices · September 12, 2025

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

European Commission updates the manual on borderline and classification decisions for medical devices and in-vitro diagnostics.

High obligation Framework Medical Devices & IVD EU-wide Device classificationMedical devicesIn vitro diagnostics

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

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