Tag Archives: European Commission

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

Commission Updates EU Medical Devices Borderline Manual

The European Commission’s Borderline and Classification Medical Devices Expert Group has published a new version of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices.  The updated manual includes a new section on software and mobile applications reflecting the growing industry of medical device software.  The manual also provides new … Continue Reading

Commission Recommendation on Unique Device Identification System in the EU Commission Recommendation on Unique Device Identification System in the EU

On 5 April, 2013 the European Commission adopted a recommendation on a common framework for a unique device identification (UDI) system in the EU. The hope is that a harmonized UDI system will facilitate device safety monitoring and reporting, recalls, and other field safety corrective actions. It will also help avoid device-related medical errors and … Continue Reading

EU to Debate Establishing a Pre-Marketing Authorization System for High Risk Devices

One of the most critical issues of the ongoing revision of the EU legislation on medical devices is whether the new rules will contain a pharma-like pre-marketing authorization regime for high risk medical devices that requires a review by a governmental regulatory authority rather than a notified body. The question is subject to intensive debate … Continue Reading
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