European Commission: Cranberry Products Are Not Medical Devices

Regulatory NewsRegulatory News | 26 May 2017 |  By 

The European Commission's regulatory committee on medical devices on 19 May voted in favor of the commission's decision that products "whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis," also known as bladder inflammation or infection, "are not medical devices within the meaning of Article 1 (2) (a) of the Medical Devices Directive."

The final decision, following a draft decision in February 2016, comes as last July, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) noted: "Products containing proanthocyanidins and/or cranberry as substance or preparation for use in urinary tract infections [UTIs] are currently marketed differently across the EU as food supplement, medical device or consumer product."

While considering the information provided by the commission, the definition of a medical device, an EC guidance document, a ruling in the Court of Justice of the European Union from 2012 and the scientific literature, CHMP said in its opinion, "The totality of data suggests that a mechanical mode of action of PACs is highly unlikely. Metabolites of PACs and other constituents of cranberry exhibit most probably a pharmacological activity."

In 2014, the French company Arkopharma had its EU medical device status revoked by France's medical products regulator (ANSM) after obtaining Class IIb medical device status for its patented cranberry-based products based on clinical data. ANSM said at the time that Arkopharma lacked the data to justify its device status.

The formal adoption and publication of the commission's decision are expected later this summer.

Adoption of the Commission decision on the qualification of cranberry products


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