Knowledge · Borderline
Borderline products: medical device, cosmetic or supplement?
Classifying borderline cases clearly — intended purpose, mode of action and claims decide.
Borderline products sit on the boundary between regulatory categories: medical device (EU MDR), cosmetic (Regulation (EC) No 1223/2009), food or supplement (LFGB) or medicinal product. The classification is not decided by marketing but by intended purpose and mode of action — documented and traceable.
The three guiding questions
- What intended purpose is claimed?
- How does the product act (physically, chemically, pharmacologically, immunologically, metabolically)?
- Where and how long is it applied (mucosa, skin, oral)?
Typical borderline cases
| Product idea | Possible category | Decisive |
|---|---|---|
| Intimate wash | Cosmetic or medical device | Claims, intended purpose |
| Moisturising gel | Cosmetic or medical device | Use purpose, site |
| Mouthwash “for sensitive gums” | Cosmetic, medical device or medicinal product | Mode of action, claim |
| Skin gel “supports wound healing” | Medical device (not cosmetic) | Medical purpose |
| Chewing gum with vitamins | Food supplement | Nutritional purpose |
Risk of wrong classification
The wrong category leads to objections, recalls and liability. Conversely, an inflated classification makes the project unnecessarily expensive. INOPREX performs this assessment as the first project step.
Frequently asked questions
Can I choose the category myself?
No — it results from intended purpose and mode of action. But you can shape formulation and claims so that a specific category is reached.
Applied to your project
We apply these rules directly to your project — from classification to market access. First assessment within two working days.