Legal Issues in Implantable Medical Devices: Liability & Hedge

Abstract

Recent advances in science and technology led consumers to benefit from better health care system and medical equipment. On the other side of the matter, regulations regarding those technologies emerged to guide sponsors and manufacturers who make the medical devices, as well as participants in clinical evaluation stage. However, as implantable medical devices appear, updated regulations are necessary to avoid potential legal issues in complicated circumstances where it is hard to recognize the implantable medical device as is, but it is closely related to one's life. In this paper, contemporary regulations around the globe are explored and discussed for more sophisticated regulation for future implantable medical devices.