Markets, standardization and innovation: reflections on the European Single Market

Abstract : In the perspective of (political) governance, technical standardisation is often seen as offering a practical compromise between (political) regulation and innovation (at the market). On one hand legal regulation is a precondition for markets as regulation provides market actors with relatively stable and calculable conditions and on the other hand regulation may become a barrier to innovation in the market. Technical standardisation offers a solution to this contradiction as regulation can be stated in more general terms — as framework directives of the EU — and allow technical standards to mediate between the relatively stable and general legal requirements and the dynamics of innovation in the market. This is, however, only part of the story and a closer look at the history of technical standardisation in EU governance (the so called New Approach and Global Approach) shows that European governance in recent decades has led to a complex architecture. In the paper we trace this development. After having rested on the Medical Devices case and on its recent problems, we conclude that the contradiction between regulation and innovation has not been removed. Instead the general legal requirements become abstract to a degree that it becomes difficult if not impossible to tell whether they have been fulfilled or not.