A recent article from Regulatory Affairs Professionals Society noted that although commonly used to treat bladder and urinary tract infections, cranberries are in fact not medical devices. The commission decided that products “whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis are not medical devices within the meaning of Article 1 (2) (a) of the Medical Devices Directive.”
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that products containing PACs and/or cranberry were marketed differently across the EU. Some called it a food supplement, while other considered it a medical device or consumer product. In the end, the CHMP decided, “the totality of data suggests that a mechanical mode of action for PACs is highly unlikely. Metabolites of PADs and other constituents of cranberry exhibit most probably a pharmacological activity.”
