The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on the classification of cranberry products (the “Cranberry Decision”). In essence, the Cranberry Decision provides 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. The European Commission adopted its draft decision based on Article 13(1)(d) of Directive 93/42/EEC (the “Medical Devices Directive”).
The vote comes more than one year after the Commission prepared a draft decision, in February 2016 (see our analysis of that draft decision here). The formal adoption and publication of the Cranberry Decision are expected later this summer. This article first briefly summarizes the regulatory context of EU borderline issues. It then explains what triggered the decision, analyzes its content, and provides a brief outlook on what is coming next. Continue Reading