EU Borderline Product Decision Cements Challenges for Devicemakers

A recent decision by the EU Court of Justice on borderline products confirms an ongoing practice by member states that can create challenges for devicemakers, says Erik Vollebregt of Axon Lawyers in the Netherlands. The judgment in case C-109/12 found that different member states may classify the same product differently, whether as a medicinal product requiring clinical data or as a medical device.
Devices & Diagnostics Letter