Market, Regulation, Market, Regulation

Christian Frankel, Jean-Pierre Galland

Research output: Chapter in Book/Report/Conference proceedingArticle in proceedingsResearchpeer-review


This paper focuses on the European Regulatory system which was settled both for opening the Single Market for products and ensuring the consumers' safety. It claims that the New Approach and Standardization, and the Global Approach to conformity assessment, which suppressed the last technical barriers to trade in Europe, realized the free movement of products by organizing progressively several orders of markets and regulation. Based on historical and institutional documents, on technical publications, and on interviews, this article relates how the European Commission and the Member States had alternatively recourse to markets and to regulations, at the three main levels of the New Approach Directives implementation. The article focuses also more specifically on the Medical Devices sector, not only because this New Approach sector has long been controversial in Europe, and has recently been concerned by an important regulatory failure, but also because it is regulated by totally other means in the United States of America. At a time when the Medical Devices sector is part of TTIP discussions, this article allows a better understanding of the diverse stakeholders and regulators positions in the EU.
Original languageEnglish
Title of host publicationEURAS Proceedings 2015 : The Role of Standards in Transatlantic Trade and Regulation
EditorsKatrine Bergh Skriver, Kai Jakobs, Jesper Jerlang
Place of PublicationAachen
PublisherVerlagshaus Mainz
Publication date2015
ISBN (Print)9783958860353
Publication statusPublished - 2015
EventThe 20th EURAS Annual Standardisation Conference: The Role of Standards in Transatlantic Trade and Regulation - Dansk Standard, København, Denmark
Duration: 22 Jun 201524 Jun 2015
Conference number: 20


ConferenceThe 20th EURAS Annual Standardisation Conference
LocationDansk Standard
Internet address

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