Dannhorn Dieter R, Schwabedissen Heidrun
Mdt medical device testing GmbH, Ochsenhausen, Germany.
Med Device Technol. 2008 Sep;19(5):16-8, 20.
Directive 2007/47/EC1 amends the earlier Medical Device and Active Implantable Medical Device Directives. Amongst its new requirements is the need for more clinical data and more frequent clinical investigations in the conformity assessment of innnovative medical devices. Details of the changes and the implications for manufacturers are outlined.
欧盟指令2007/47/EC修订了早期的《医疗器械指令》和《有源植入性医疗器械指令》。其新要求包括在创新医疗器械的合格评定中需要更多临床数据和更频繁的临床调查。文中概述了这些变化的细节及其对制造商的影响。
