[2025-09-12] In September 2025, the European Commission’s Borderline and Classification Working Group published a further update of the reference document on borderline products and classification of medical devices (MDs) and in vitro diagnostic medical devices (IVDDs).
Purpose of the reference document
This is a 28-page guide, entitled “Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices”, version 4. It aims to provide clarifications for:
- Determining whether a product falls under Regulation (EU) 2017/745 on medical devices or under Regulation (EU) 2017/746 on in vitro diagnostic medical devices;
- Understand the borderline cases between MDs, drugs, biocides, cosmetics, foodstuffs, PPE (personal protective equipment) or consumer products;
- Ensure consistent application of MDs and IVDDs classification rules throughout the European Union.
New entries in version 4
This new version adds several new examples of borderline product qualification and classification:
- classification of red blood cell additive solutions containing adenine;
- classification of dual action cream with menthol and capsaicin;
- lactose tablets for vaginal use;
- qualification of micro-abrasion dental stain removers;
- qualification of medical examination table covers;
- mobile sterile air system.
However, there are no new entries in the section dedicated to IVDD.
As a reminder, a network article deals with the previous version (version 3) of the document.
Conclusion
Rather than adding to and (re)explaining the rules for product qualification and classification, this reference document takes the approach of providing concrete examples. Manufacturers of similar devices can use or be inspired by the arguments and results provided to classify their own products.
Please note that the guide recommends referring to other documents for further details, such as :
- MDCG 2022-5 Rev.1 ” Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices” for borderline products;
- MDCG 2021-24 ” Guidance on classification of medical devices ” for the classification of MDs; and
- MDCG 2020-16 Rev.4 ” Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746 ” for the classification of IVDDs.
Article written by Christophe Saillet, member of the DMEXPERTS network.