Version 4 of the Manual on borderline and classification for medical devices (Sept. 2025)

This reference document, developed by the Borderline and Classification Working Group (subgroup of the Medical Device Coordination Group), provides essential clarifications to:

• Determine whether a product falls under Regulation (EU) 2017/745 on medical devices (MDR) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
• Understand borderline cases between medical devices, medicinal products, biocides, cosmetics, food, PPE, or general consumer products.
• Ensure consistent application of the classification rules for MDs and IVDs across the EU.

This new edition includes multiple concrete examples of qualification and classification (endodontic irrigation solutions, dual-action creams, health apps, implantable devices, etc.), supporting a more harmonized interpretation of EU regulations for the benefit of patient safety and the internal market.

This document is a practical tool for national authorities, manufacturers, and healthcare professionals.

DOWNLOAD THE NEW VERSION OF THE MANUAL