EU breast implant standard withdrawn
This article was originally published in Clinica
Executive Summary
The European Commission and European Standards Commission (CEN) have jointly agreed that compliance with the breast implant standard EN 12180:2000, published as a harmonised standard on July 31 2002, is no longer adequate for manufacturers to claim that their devices are safe and meet EU requirements. They have therefore decided to withdraw it from the list of standards published in the Official Journal of the European Communities. The Commission Decision on this matter was published in the Official Journal of the European Union on April 24 and addressed to member states and refers to EN 12180:2000 Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants.