Chapter 106 - European Union medical device legislation, vigilance, and metrology system

Abstract

Discoveries and technological developments during 19th and 20th century led to the development of significant number of medical devices causing the transformation of the way medical care is delivered today. Diversity and innovativeness of medical devices, significantly contribute to improvement in quality and efficiency of healthcare services. Various regulatory bodies provide definition of this term such as US Food and Drug Administration (US FDA), World Health Organization (WHO), and European Commission (EC) which gives the most comprehensive one. Medical devices have become a critical component of health care, as they enable healthcare providers to diagnose, treat, monitor, and provide therapy to patients within an appropriate environment of care. An uncontrolled spread and use of medical technology as well as a noncritical acceptance of innovations are raising the question of performance accuracy of medical devices and patient safety. Because of this working vigilance system is very important to ensure care is provided to the end user (patient) in terms of increasing safety and quality. This chapter provides an overview of regulations on medical devices at European level and medical device vigilance system introducing concept of metrology to healthcare assessment.