EC Public Health · April 22, 2026

Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 – Update

Original title: Update - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5

Version 5 update to the EC manual on borderline and classification decisions under the MDR and IVDR.

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

News announcement 22 April 2026 Update - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 Update - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 1 min read

Dates and deadlines

Regulatory Deadline

April 22, 2026

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