Tag Archives: Borderline

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

This article was originally posted on our sister blog Inside 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 … Continue Reading

EU Medical Devices Regulation Series: Potential for Easing Borderline Determinations?

This article was originally posted on our sister blog Inside Medical Devices Earlier this week, in a plenary vote, the EU Parliament endorsed the texts of the Regulation on Medical Devices (the “Regulation”—latest version available here) and the parallel Regulation on In-Vitro Diagnostic Medical Devices (the “IVD Regulation”—latest version available here).  This presents a good … Continue Reading

EU Court Of Justice Further Clarifies Definition Of Medicinal Products – And Raises New Questions

On 10 July 2014, the Court of Justice of the European Union (CJEU) gave its judgment in a case involving “legal highs” that a substance which only influences physiological functions without any beneficial effects on human health, shall not be considered as a medicinal product within the meaning of Article 1(2)(b) of Directive 2001/83/EC (decision … Continue Reading

New MHRA Guidance on Borderline Medical Devices

In February 2014, the MHRA published new guidance on borderline medical devices.  The guidance considers only medical devices within the terms of the Medical Device Directive and not the Active Implantable Medical Devices Directive or In Vitro Medical Devices Directive. Purpose and mode of action The MHRA makes clear that borderline determinations “will be based on the stated intended purpose of … Continue Reading
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