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International Medical Device Regulatory Monitor
July 2012 | Vol. 20 No. 7
European Parliament Endorses Premarket Controls for Riskiest Medical Devices
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.
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