In Vitro Diagnostic Medical Devices Law And Practice In Five Eu Member States

Author : Bernhard M. Maassen
Publisher : Springer Science & Business Media
ISBN 13 : 9401583196
Total Pages : 130 pages
Book Rating : 4.90/5 ( download)

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Download or read book In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States written by Bernhard M. Maassen and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preface by T. Morrison, Director-General of the European Diagnostic Manufacturers Association. Contributors: W. Kewenig; G. Forlani, J. Marriage, G. Ulloa This book is based upon a report prepared at the request of the European Commission. Its purpose is to set out the existing laws regulating the development, production, distribution and use of in vitro diagnostic medical devices (IVDMD) in the U.K., Germany, France, Italy and Spain. Each national section has the same structure and covers the same ground in order to enable comparisons. IVDM Devices includes not only reagents, but also technical instruments, or combination of both, for human use. The book is directed towards industry and the regulation is covered with a high degree of specificity. This reference book, completely written in English, is the only comprehensive exposition of the laws of the five countries regarding IVDM Devices available. It is also the most convenient means of comparing those laws. As such, it will be a useful guide to all IVDM Devices manufacturers interested in the European market.

Author : Petri Pommelin
Publisher :
ISBN 13 : 9789515681201
Total Pages : 92 pages
Book Rating : 4.00/5 ( download)

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Download or read book The Survival Guide to Eu Medical Device Regulations written by Petri Pommelin and published by . This book was released on 2017-06-20 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Regulations for medical devices and in vitro diagnostic medical devices were published in the Official Journal of the European Union on 5 May 2017, and they entered into force 26 May 2017. A regulation is a legal act of the European Union that becomes immediately enforceable as law in all Member States simultaneously. This book gives guidance on the definitions, the key concepts and the main elements. The intention is to provide an introduction that supports the further reading of the challenging content of the Regulations.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.06/5 ( download)

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Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Author : Michelle Egan
Publisher : OUP Oxford
ISBN 13 : 0191529524
Total Pages : 382 pages
Book Rating : 4.28/5 ( download)

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Download or read book Constructing a European Market written by Michelle Egan and published by OUP Oxford. This book was released on 2001-06-14 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Efforts to tackle the trade impeding effects of divergent standards and regulations are at the core of European economic relations. This volume draws on literature from several disciplines to develop a comprehensive account of the regulatory strategies and institutional arrangements adopted by the EU in promoting the single market in goods. It provides a historical overview and detailed cases studies of the various policy initiatives that have altered the boundaries between the public and private sector in fostering market integration. Tackling interstate barriers to trade has relied heavily on European law to shape the framework of relations between states, and trade liberalization has been facilitated by legal rulings resolving territorial conflicts over regulatory jurisdiction and authority. The European Court of Justice has actively shaped markets, acting as a 'free trade umpire' in balancing the goals of market liberalization and market regulation while fostering market compliance. Although markets are absolutely dependent on public authority, the institutional innovation of the EU has been to use the private sector in an ancillary role to the state. By delegating responsibility to set standards for market access, the EU has chosen to draw on the resources of private actors, resulting in a system of governance that is a distinctive, hybrid model of regulation composed of state and non-state actors. Though the "outsourcing" of public sector regulatory activity was expected to be more effective than the process of regulatory harmonization, progress has been difficult. The current deficit in setting standards for European-wide market access raises concerns about the efficiency and effectiveness of such a regulatory regime. Egan provides a detailed evaluation of that process, highlighting regulatory gaps in the single market and the need to focus not only on the process of market integration, but also its outcome and impact on European business. Comparisons with American efforts to create a national market are made throughout to demonstrate the difficulties of constructing and maintaining a single market. American and European efforts to devise a uniform market for commerce and trade have involved both public and private authorities, though with different degrees of coordination and centralization, as many of the strategies undertaken by the EU echo earlier American market-building efforts.

Author : Michael Cheng
Publisher : World Health Organization
ISBN 13 : 9241546182
Total Pages : 54 pages
Book Rating : 4.88/5 ( download)

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Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.58/5 ( download)

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Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Author : Christa Altenstetter
Publisher : Routledge
ISBN 13 : 1351506285
Total Pages : 277 pages
Book Rating : 4.81/5 ( download)

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Download or read book Medical Devices written by Christa Altenstetter and published by Routledge. This book was released on 2017-09-08 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care, genetic testing, clinical trials, and experimental clinical investigations. Without medical devices, there is no clinical research or patient care. Without life-adjusting devices, there are no medical procedures or surgery. Without life-saving and life-maintaining devices, there is no improvement in well-being and quality of life. Without innovative medical devices and experimentation, there can be no medical progress or patient safety. Medical devices and medical technology are used to create or support many different products and medical-surgical procedures. This volume on the regulation of medical devices in the European Union, with a focus on France, tackles a topic of interdisciplinary interest and significance for policymakers in countries around the globe. The EU regulatory regime is one of three global regional regimes, and medical products manufactured in EU countries are sold worldwide. As countries confront an aging population on a global scale, with associated increases in chronic diseases, physical handicaps, and multi-morbidity, there will inevitably be an increase in the demand for health services and, concomitantly, the use of medical devices in medical and surgical procedures. This will be the case regardless of whether services are delivered in hospitals, doctors' offices, or at home. The associated risks of a particular device will be the same whatever the country of origin for the device, or where the need occurs. Revolutionary medical advances increase diagnostic capabilities, but they increase the potential of harm and risks to patients. Medical technologies and devices are used ethically most of the time; yet they have the potential for unethical use when scientific medicine is elevated over human life and death. Assumptions that are taken for granted can be dangerous to a patient's health. That is why our understanding of appropriate and effective regulation of medical devices is significant to all people on all continents.

Author : European Commission
Publisher :
ISBN 13 :
Total Pages : 124 pages
Book Rating : 4.37/5 ( download)

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Download or read book Guide to the Implementation of Directives Based on the New Approach and the Global Approach written by European Commission and published by . This book was released on 2000 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Gloria Hall
Publisher :
ISBN 13 : 9781947493674
Total Pages : pages
Book Rating : 4.71/5 ( download)

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Download or read book Fundamentals of Medical Device Regulations, Fourth Edition written by Gloria Hall and published by . This book was released on 2021-07-23 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264805907
Total Pages : 447 pages
Book Rating : 4.03/5 ( download)

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Download or read book Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.