On 8 November 2016, the European Commission published the opinion of the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) concerning the principal mode of action of proanthocyanidins present in cranberry extracts and included in products intended to be used by their manufacturers for prevention and treatment of urinary tract infections.
The scientific opinion of the CHMP was requested by the European Commission. The Institution is currently preparing a decision intended to clarify whether or not products of which the principal mode of action depends on proanthocyanidins should be considered to fall within the definition of a medical device. The decision will be based on the procedure provided in Article 13.1(d) of the Medical Devices Directive which was initiated by the French competent authorities. This Article permits the EU Member States to request that the European Commission take the measures necessary to determine whether a product or product group fall within the definition of a medical device in the EU.
The classification of products of which the principal mode of action depends on proanthocyanidins currently varies between EU Member States. In some countries these products are marketed as medical devices, in others as food supplements or as cosmetics.
The European Commission explains on its website that the Institution’s preliminary assessment, confirmed by the view of the majority of EU Member States is that this type of products should not be considered to constitute a medical device. This is because their principal mode of action is achieved by pharmacological, immunological or metabolic means. Products classified in the EU as medical devices typically function by physical/mechanical means.
However, as a number of EU Member States and representatives of the medical devices industry express the opposite view, the European Commission decided to request a scientific opinion from the CHMP.
The CHMP opinion
The CHMP’s opinion confirmed the preliminary assessment of the European Commission. The CHMP stated that although there are gaps in the scientific knowledge concerning the mode of action of proanthocyanidins, the totality of data suggests that a mechanical mode of action of proanthocyanidins is highly unlikely. Metabolites of proanthocyanidins and other constituents of cranberry rather most probably exhibit a pharmacological activity.
In light of this scientific opinion, the European Commission is expected to adopt a decision clarifying that products intended to prevent or treat cystitis and depending on proanthocyanidins present in cranberry extract, do not fall within the definition of a medical device in the EU. This is due to the fact that they do not have a mechanical mode of action.