Lessons in Compliance – What Medical Devices Manufacturers Can Learn From Recent EU Enforcement Landscape
Medical devices manufacturers are braced for the overhaul of the EU Medical Devices Directives. New Regulations, which are closer to final adoption than ever (although not quite there yet), are expected to clarify the regulation of medical devices in Europe – at least once the delegated and implementing acts have been put in place. As the closing of the first round of trialogue meetings in December did not see a common position between the Council of the European Union (Council) and the European Parliament (Parliament), adoption of the new Regulations is (optimistically) anticipated in mid-2016. The Regulations are expected to apply three years (for medical devices and implantable medical devices) and five years (for in vitro diagnostics medical devices) after adoption.
This article originally appeared in Who’s Who Legal: Life Sciences 2016.