EU breast implant Communication adoption:
This article was originally published in Clinica
Executive Summary
The European Commission's Communication on silicone gel implants, which will introduce stricter requirements for these products following safety concerns, was due to be adopted by medical device experts from the EU member states by written procedure as Clinica went to press. The rules set out a clear interpretation of the Medical Devices Directive's requirements for silicone gel breast implants for manufacturers, notified bodies and member states (see Clinica No 977, p 2).