On September 12, 2025, the DG Health and Food Safety of the European Commission officially published the fourth Version of the Borderline & Classification Manual, providing updated guidance under the EU Regulations 2017/745 (MDR) and 2017/746 (IVDR).
The manual clarifies how to classify products at the boundary between medical devices and medicinal products, offering practical examples and guidance on mode of action, intended purpose, and classification criteria.
Published Borderline Cases
1- Red Blood Cell (RBC) Additive Solutions with Adenine
- Purpose: Extend RBC shelf life, maintain ATP and cell shape.
- Mechanism: Adenine participates in RBC metabolism, restoring AMP and supporting metabolic function during storage.
- Classification outcome: Metabolic and/or pharmacological action; according to Rule 14, Annex VIII MDR, the device is Class III.
2- Dual-Action Cream with Menthol and Capsaicin
- Purpose: Relieve muscle and joint pain with “cooling and warming” effects.
- Mechanism: Menthol acts on TRP ion channels (cooling/analgesic), capsaicin provides mild warming.
- Outcome: Principal action is pharmacological → product is a medicinal product, not a medical device.
3- Vaginal Lactose Tablets
- Purpose: Reduce vaginal odor and discharge, relieve irritation.
- Mechanism: Lactose nourishes vaginal lactobacilli; their metabolism produces lactic acid and other growth-inhibiting substances.
- Outcome: Action is metabolic → not a medical device, but a product with metabolic action.
4- Dental Stain Removers (Microabrasion)
- Purpose: Improve teeth appearance.
- Mechanism: Mechanical/chemical removal of stains.
- Outcome: Aesthetic action, not therapeutic → not a medical device, classified as cosmetic/aesthetic.
5- Medical Examination Table Covers
- Purpose: Hygiene and prevention of pathogen transmission.
- Outcome: Specific medical purpose for disease prevention → qualifies as a medical device (art. 2(1) MDR).
6- Mobile Sterile Air System
- Purpose: Create a sterile zone via filters and laminar airflow.
- Mechanism: Controls the environment; does not act directly on the human body.
- Outcome: No direct medical purpose → not a medical device.
Version 4 of the MDCG manual highlights the importance of analyzing intended purpose, mechanism of action, and the role of the substance when determining product qualification. Evaluating borderline cases often requires deep expertise in pharmacology, metabolism, and toxicology. Engaging an experienced toxicologist is crucial for accurately assessing the mechanism of action and supporting regulatory classification decisions.
