The European legislation on medical devices.

The protection of health and safety of patients and users, is the main objective of the comprehensive, harmonised legislation created in the EU, in the area of medical devices. In this paper, a brief description of the legislative programme is presented,-giving details on the three medical device directives, as well as their transposition. A detailed analysis of the directives context follows, with the steps and actions that all involved parties have followed or need to follow to ensure their uniform application.