European Union regulation and standards for medical technology in a global market place

摘要

Since 1985, European Union (EU) countries have decided on a new procedure for legislation and regulations concerning industrial products (the so-called "new approach"). The basic philosophy is that mandatory laws (EU Directives) define only the essential requirements for safety and performance, in each class of products, which must be fulfilled in order to have free circulation inside the EU countries. Directives do not contain the specific technical requirements which are demanded by technical standards, but introduce the basic philosophy of general definitions, classes and relative modalities for certification, the tasks of manufacturers, political authorities, notified bodies and users, technology evaluation, market assessment, and so on. The important market segment of medical equipment and devices is regulated by means of three Directives, one of which is still at its final stage before official approval. An important integration of legislative (mandatory) requirements with technical (non-mandatory) requirements has been reached, in order to fulfil two objectives: (i) an easy exchange of products inside the EU countries, and (ii) maintaining a reasonably high level of safety and performance standards for this very delicate segment of the industrial market. In this paper, the basic characteristics of this regulation policy are reviewed, with the important implications of interacting and integrating with other regulations and standards in a global market dimension.