Cranberry-based products set to lose "medical device" categorization in EU

28 Jul 2017 --- The formal adoption of the EU Regulatory Committee on Medical Devices’ “cranberry decision” on cranberry products that are intended to prevent or treat cystitis is expected imminently. The decision is expected to come into effect this summer and means that “cranberry products currently sold as medical devices will have to be re-categorized either as dietary supplements or drugs,” Dr. Iris Hardewig, Consulting & Strategic Innovation Senior Consultant at consulting and CRO services company analyze & realize, tells NutritionInsight.

The ruling was voted on by the EU Regulatory Committee on Medical Devices on May 19, 2017 in favor of the European Commission’s draft decision. It means that cranberry products intended to prevent or treat cystitis and that have a principal intended action based on proanthocyanidins (“PACs”) do not fall within the definition of medical devices.

While the medical devices ruling is a general blow for many nutrition products – probiotics, for example, will no longer be certified as medical devices, says Hardewig – there could be some benefits for others. “There is still a chance for oral or nasal products to be marketed as medical [devices,] but no longer as class I products (low risk class,)” she adds. “These products will at least be categorized as class II, and many of them as class III products.”

In terms of the impact on the decision for cranberry-based products, existing medical devices based on cranberry will have to switch to another category, Hardewig notes. But there are also opportunities: “We do expect a growth in cranberry based dietary supplements. The EMA is currently preparing a new HMPC monograph on cranberry, and this will support the registration of cranberry products as traditional herbal Medicinal Product (THMP) in the EU.

“[THMP] may be a good alternative option for the manufacturers of cranberry products, because this product category may allow the making of claims related to cystitis. However, they would have to comply with GMP standards for the production of THMP.”

The legal definition of a medical device, according to the European Medical Devices Directive, is: “a product intended to be used for therapeutic purposes like prevention, treatment or alleviation of disease.” Classifying a product as a medical device could potentially previously have been seen as an alternative for companies that could not make positively evaluated specific health claims on their cranberry products.

Discussing the consequences of the decision for the popular Ocean Spray cranberry beverage, Kay Schumacher, product development and application team manager at bolasco, which distributes the brand in Europe, says it should be minimally affected. “Our point of view is that the cranberry itself has got a health halo around it,” he says. “Everyone knows that the cranberry is healthy, no matter if you have the health claim or not, so therefore the soft communication about the healthiness of cranberry has the biggest impact…to have a successful ingredient for the customer.”

By Paul Creasy