Definition and International Regulations for Medical Devices

Abstract

The term medical device refers to a wide variety of products. They range from simple low-risk devices such as stethoscopes and syringes, through imaging device and in vitro diagnostic, up to high-risk biocompatible implants, such as orthopaedic prostheses and pacemakers.

The number and variety of medical devices are increasing as new software and hardware applications, new materials and new combination products are developed and to classify these according to the intended purpose and the different options may be a difficult task.

The identification of a product as a medical device and the further classification into classes of risk is the base for the application of the correct regulatory path worldwide, although differences exist at national level in such classifications.

The development of consistent, harmonized definitions for the terms “medical device” and “in vitro diagnostic medical device” would offer significant benefits to the manufacturer, user, patient and to regulatory authorities. This can also support the global convergence of regulatory systems.

This chapter aims to give a comprehensive description of the different regulations concerning the medical devices worldwide with special reference to the EU Medical Device Directive. The role and importance of the technical standards are also described.