Tag Archives: European Medicines Agency

EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices

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 … Continue Reading

Lead Member of the European Parliament Proposes a Pre-Marketing Authorization System

As announced in our previous post, the rapporteur (i.e., the leader of the parliamentary process) for the new Regulation on medical devices, Mrs. Dagmar ROTH-BEHRENDT, has proposed the introduction of a pharma-like pre-marketing authorization regime for high risk medical devices in the EU. In her recent report submitted to the ENVI Committee of the European Parliament (the parliamentary … Continue Reading
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