[Evaluation of new implantable medical devices].Bull Acad Natl Med. 2012 Jan; 196(1):175-92.BA
Complex administrative procedures have gradually been established for the evaluation of implantable medical devices, resulting in improved patient safety. These procedures include in vitro testing, animal experimentation, clinical premarketing studies, and post-market surveillance. Further improvements are needed, however, including more independent experts and clinical studies, while ensuring that the approval process is neither to slow nor too hasty.