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An easy-to-use introductory guide for industry and gov¿t. officials on the principles and concepts behind the European Union¿s (EU) ¿New Approach¿ laws and directives. Will help bus. and gov¿t. officials understand the new laws, the EU¿s standardization process, and the relationships between the European Comm. and the European standardization bodies in the EU. Also provides info. on the EU¿s approach to conformity assessment and requirements for obtaining the CE mark to gain access to the European Market. Offers explanations of such requirements as: notified bodies, conformity assessment modules, supplier¿s declaration of conformity, tech. construction files, user manuals, authorized rep., and product liability in the EU. Charts and tables.
Standards are a feature of virtually all areas of trade in products and services. Yet, although standards may achieve an efficient economic exchange, they have discriminatory consequences for trading partners when governments formulate or apply them in such a way as to cause obstacles to trade, thus enrolling standards among the increasingly significant 'non-tariff barriers' regulated by the WTO. This unique and original study analyses the functions that standards fulfil in the market, their effect on trade, and the legal regime based on harmonization, equivalence and mutual recognition developed by the WTO to deal with standards. The author investigates the way in which both the WTO Technical Barriers to Trade (TBT) and the Sanitary and Phytosanitary (SPS) Measures Agreements regulate these three tools, and discusses key topics including: The definition of the concept 'International Standard' in the TBT Agreement. Guidelines on equivalence issued by organizations such as the Codex Alimentarius Commission, the World Organization for Animal Health and the International Plant Protection Convention. Parallels between the EC mutual recognition regime and the WTO system. This is the first work on its subject. With its detailed and practical analysis of WTO law on standards, the book is a fundamental reference for practitioners, academics and policy makers in international trade law.
Widely regarded as the standard text on EMC, Tim Williams' book provides all the key information needed to meet the requirements of the latest EMC Directive. Most importantly, it shows how to incorporate EMC principles into the product design process, avoiding cost and performance penalties, meeting the needs of specific standards and resulting in a better overall product. As well as covering the very latest legal requirements, the fourth edition has been thoroughly updated in line with the latest best practice in EMC compliance and product design. Coverage has been considerably expanded to include the R&TTE and Automotive EMC Directives, as well the military aerospace standards of DEF STAN 59-41 and DO160E. A new chapter on systems EMC is included, while short case studies demonstrate how EMC product design is put into practice. Tim Williams has worked for a variety of companies as an electronic design engineer over the last 25 years. He has monitored the progress of the EMC Directive and its associated standards since it was first made public. He now runs his own consultancy specialising in EMC design and test advice and training. - Includes the compliance procedures of the latest EMC Directive: 2004/108/EC - Short case studies demonstrating how EMC product design is put into practice - Packed full with many new chapters including: The R&TTE Directive and the Automotive EMC Directive looking at compliance aspects of radio and telecom terminal equipment and automotive electronic products; New chapter on military aerospace standards of DEP STAN 59-41 and DO1 60E; New chapter on systems EMC
Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
OECD's 2000 review of regulatory reform in Denmark.
This book brings together the study of transnationalization in three institutional fields: civil society, state and the economy. It also extends the research of processes of transnationalization to evolving new democracies and emerging market economies.
One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.
While the internal market has been at the heart of the European project from the very beginning, it has rarely been the subject of sustained and comprehensive scholarly examination in its entirety. In the face of profound legal, political and policy pressures, this timely Research Handbook reflects on the cutting-edge issues, horizontal themes and the big questions which illuminate the shape of the internal market. It places the law and policy of the internal market within the context of the financial crisis and the existential questions this has raised for future European integration.