02/06/2017

Borderline products: Cranberry products cannot be regarded as medical devices

The European Commission’s Regulatory Committee on Medical Devices has adopted a Commission Decision on the qualification of cranberry products. According to the Decision, cranberry products do not fall within the definition of medical devices set out in the Medical Devices Directive.  

The European Commission’s Regulatory Committee on Medical Devices has adopted a Commission Implementing Decision on the qualification of cranberry products. The Decision states that products “whose principal intended action, depending on proanthocyanidins present in cranberry (Vaccinium Macrocarpon) 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 Decision was taken upon the request from France in accordance with Article 13 (1) (d) of the Medical Devices Directive. It also follows the European Medicines Agency’s (EMA) scientific opinion of 22 July 2016 which noted that “Products containing proanthocyanidins and/or cranberry as substance or preparation for use in urinary tract infections are currently marketed differently across the EU as food supplement, medical device or consumer product”. Furthermore, EMA concluded that the principal intended action of this group of products is most probably pharmacological and not a mechanical mode which would qualify them as medical devices.

It will nevertheless be up to the Members States’ competent authorities to determine whether these products are food supplements or medicinal products. Should they be considered as food supplements, all health-related communications regarding those products will fall within the scope of the Nutrition and Health Claims Regulation.

The formal adoption and publication of the Decision are planned later this summer.