EC Public Health · April 22, 2026

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

Version 5 of the EC manual on borderline and classification decisions under MDR and IVDR published.

High obligation Framework Medical Devices & IVD Digital Health & AI EU-wide Medical devicesIn vitro diagnosticsDevice classificationCE marking

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

Read the official source ↗

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