Version 5 of the Manual on borderline and classification under MDR 2017/745 and IVDR 2017/746 published

Published: 22 Apr 2026

The European Commission published version 5 (April 2026) of the Borderline and Classification Manual, prepared by the Borderline and Classification Working Group of the Medical Device Coordination Group. It covers borderlines with medicinal products, cosmetics, food, PPE and other categories, plus MDR classification rules 1-22 and IVDR qualification and classification. The manual is non-binding; only the CJEU gives authoritative interpretation, so teams should check their product qualification and classification against the updated positions.

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

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