FDAnews Device Daily Bulletin

The EU is one step closer to mandating premarket authorization for Class IIb and Class III medical devices, following the European Parliament’s adoption of proposals aimed at beefing up device regulation in the wake of the PIP silicone gel breast implant scandal. The June 14 resolution calls for stronger postmarket surveillance and safety controls, better coordination of adverse event reports and systematic access to such reports by notified bodies. Annual, unannounced inspections of device facilities by national authorities, tighter oversight of notified bodies and more sample testing of products already on the market would be part of the fix as well.
Clinical Trials Advisor