European Parliament Calls for Premarket Authorization System in Wake of PIP

As fallout from the defective PIP breast implant imbroglio continues, a European Parliament health committee is calling for tough new regulatory controls, including the creation of a premarket authorization system for certain categories of medical devices — an idea that brought immediate kickback from industry. In a unanimous resolution April 25, the Committee on Environment, Public Health and Food Safety also urges strengthened postmarket surveillance and safety controls, better coordination of adverse event reports and systematic access for notified bodies to such reports.
International Medical Device Regulatory Monitor