Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
466869 | Computer Law & Security Review | 2013 | 15 Pages |
Abstract
The recent scandals involving the sale and manufacture of defective medical devices such as the PIP breast implants and the De Puy Implants have resulted in the long-awaited modernisation of the Medical Device Directive. Taking cognizance of the increasing integration of medical devices and technology, as well as the importance of electronic information, the proposed EU Regulation on Medical Devices promises greater European control on Notifying Bodies and more transparency to ensure patient's safety. This paper discusses the current directives and proposed legislation as well as the liabilities of manufacturers and software vendors for product failure.
Related Topics
Physical Sciences and Engineering
Computer Science
Computer Science (General)
Authors
Sylvia Kierkegaard, Patrick Kierkegaard,