FDAnews Device Daily Bulletin

EU Regulators Affirm That Cranberry Products Are Not Medical Devices

July 6, 2017

An EU committee approved the European Commission’s decision that cranberry products are not medical devices — in a decision with broader implications for “borderline” situations where a product’s primary mode of action is unclear.

The so-called “Cranberry Decision” ruled that cranberry products with a primary intended action based on proanthocyanidins and used for cystitis treatment or prevention do not constitute devices. The European Commission issued its draft decision in February 2016, and formal adoption of the decision is expected later this summer.

The European Medical Association’s Committee for Medicinal Products for Human Use reviewed the draft decision, the scientific literature and previous EC guidance and concluded that a mechanical mode of action of proanthocyanidins is “highly unlikely.” The products are most likely properly classified as pharmacological, according to the committee.

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