ABSTRACT

This chapter explores the medical device industry in Europe and in France and compares France's medical device innovative capabilities with those of Germany and the UK. The European medical device industry is embedded not only in the political economy of each country's distinctive government-business relations, but it also faces structural constraints arising from highly regulated health-care systems based on a social model of health care. The medical device industry in France has been weak for a variety of reasons. It lacks innovation, production, scientific and technical status, and has had difficulty attracting qualified employees. Trade associations engage in a host of political and scientific-technical activities in Brussels and France, serving as intermediaries between national and international firms and European Union (EU) and national authorities. The regulation of the in vitro diagnostic industry in France began in 1984 after a 1982 law required the registration of diagnostic products with the National Health Laboratory.