EU countries must take up existing tools for regulatory change
This article was originally published in Clinica
Member states need to make a formal request to the European Commission through its Committee on Medical Devices to reclassify implants from class IIb to class III, Cornelis Brekelmans, head of the medical devices unit at the European Commission's Directorate General Enterprise, told a London meeting on September 19. "The initiative cannot come from the Commission, it must come from member states," he said. "As soon as we have a formal request we will deal with it," he added.