On 26 September, 2012 the European Commission released its proposals for the future regulation of medical devices. Since their release one year ago, these proposals have been discussed in the European Parliament and in the European Council and should be adopted in 2014. The two proposed EU Regulations will replace the three Directives on Active Implantable Medical Devices (AIMD), Medical Devices (MDD), and In Vitro Diagnostic Medical Devices (IVDD), and will have dramatic implications for Medical Device Manufacturers. In this paper we address the main changes introduced in the proposed regulations as well as how they would impact US companies, from a regulatory and translation perspective.