1 Administration, Department of Computer Science, Faculty of Science, Københavns Universitet2 University of Southampton3 Department of Computer Science, Faculty of Science, Københavns Universitet4 University of Southampton5 Department of Computer Science, Faculty of Science, Københavns Universitet
medical devices, toxicity, virus and fraud
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.
Computer Law and Security Review, 2013, Vol 29, Issue 1, p. 13-27