Version 5 of Manual on borderline and classification for MDs and IVDs (April 2026)

A new version of the Manual on Borderline and Classification under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) has been published (Version 5 – April 2026).

Developed by the Borderline and Classification Working Group (BCWG), a subgroup of the Medical Device Coordination Group (MDCG), this manual serves as a key reference tool to support a consistent application of EU medical device legislation.

It provides practical guidance to:

• determine whether a product qualifies as a medical device, an IVD, or another regulated product category,
• address borderline cases between medical devices and other regulatory frameworks (e.g. medicinal products, cosmetics, biocides),
• support the application of classification rules under the MDR and IVDR.

The manual reflects the agreements reached by competent Member State authorities, following discussions held under the Helsinki Procedure, and contributes to a more harmonized interpretation of EU medical device legislation.

A practical reference for regulators, manufacturers, and regulatory affairs professionals involved in the qualification and classification of medical devices and IVDs.

Note: The previous Manual issued under Directive 93/42/EC on medical devices, Directive 90/385/EEC on active implantable medical devices and Directive 98/79/EC on in vitro diagnostic medical devices will not be updated anymore.

DOWNLOAD THE MANUAL VERSION 5 – APRIL 2026