EU breast implant rules delayed:
This article was originally published in Clinica
The new European Commission rules on silicone breast implants failed to materialise by the end of July, as had been promised by European Commissioner for Enterprise, Erkki Liikanen. They will not now be issued before September because of the summer recess. The rules will set out a clear interpretation of the Medical Devices Directive's requirements for silicone gel breast implants for manufacturers, notified bodies and member states. They will include an upgrade in the conformity assessment procedures for these products, from Class IIb to Class III, through a Decision (which is enforceable), and will formally invite member states to adopt a national system of patient consent (see Clinica No 962, p 4).
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