Tag Archives: medicines

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

First European Commission Borderline Decision: Does it Answer or Raise Questions?

The European Commission is preparing its first borderline decision under Article 13(1)d of Medical Devices Directive 93/42 (“the Article 13 Decision”). The draft is available here. This provision allows Member States to request that the European Commission decide whether a specific product should be considered a medical device.  The draft Article 13 Decision holds that … Continue Reading

EU Device Regulation Seeks to Enhance Legal Certainty Through Clarified Scope and EU-wide Classification of “Borderline” Products

The application of different regulatory regimes to so-called “borderline” products and regulatory gaps for certain products compromise both the protection of patient safety and the creation of the internal market in the European Union.  The European Commission has proposed a revision to the regulatory framework for medical devices that aims to increase the legal certainty … Continue Reading