Pharmacological effects of a product for the treatment of cystitis and urinary tract infections
Judgment of the Cologne Higher Regional Court of 23.12.2020, 6U18/20
An interesting decision on the classification and effect of D-Mannose. A product for the treatment and prevention of cystitis whose essential active ingredient, D-mannose, is a simple sugar that binds the adhesin FimH of the Escherichia coli bacterium, preventing it from attaching to the bladder wall and invading human cells, Has a pharmacological effect and is not marketable as a medical device.
The case law on the delimitation of health products based on their effect, specifically the pharmacological effect of medicinal products, is manageable. In this respect, this case law on the effect of D-mannose in the specific context of cystitis and the classification as a functional medicinal product of the product marketed as a medical device is highly interesting.
You can read the decision here .