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

Author : Bernhard M. Maassen,R. Whaite
Publisher : Springer Science & Business Media
Page : 130 pages
File Size : 42,7 Mb
Release : 2013-03-09
Category : Law
ISBN : 9789401583190

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In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States by Bernhard M. Maassen,R. Whaite Pdf

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 : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 141 pages
File Size : 54,9 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906

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Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

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 : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 53,7 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188

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Medical Device Regulations by Michael Cheng,World Health Organization Pdf

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 : Jelena Madir
Publisher : Edward Elgar Publishing
Page : 394 pages
File Size : 43,6 Mb
Release : 2020-10-30
Category : Law
ISBN : 9781839104909

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HealthTech by Jelena Madir Pdf

This comprehensive book provides a detailed survey and practical examination of a wide range of legal and regulatory topics in HealthTech. Key features include: • Analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers • Examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges • Guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market • Discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.

Author : Michelle Egan
Publisher : OUP Oxford
Page : 382 pages
File Size : 46,7 Mb
Release : 2001-06-14
Category : Political Science
ISBN : 9780191529528

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Constructing a European Market by Michelle Egan Pdf

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 : Christa Altenstetter
Publisher : Routledge
Page : 277 pages
File Size : 54,5 Mb
Release : 2017-09-08
Category : Medical
ISBN : 9781351506281

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Medical Devices by Christa Altenstetter Pdf

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 : OECD,World Health Organization
Publisher : OECD Publishing
Page : 128 pages
File Size : 41,6 Mb
Release : 2019-10-17
Category : Electronic
ISBN : 9789264805903

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Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies by OECD,World Health Organization Pdf

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.

Author : Gloria Hall
Publisher : Unknown
Page : 128 pages
File Size : 42,7 Mb
Release : 2021-07-23
Category : Electronic
ISBN : 1947493671

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Fundamentals of Medical Device Regulations, Fourth Edition by Gloria Hall Pdf

Author : World Intellectual Property Organization
Publisher : WIPO
Page : 259 pages
File Size : 43,5 Mb
Release : 2013
Category : Law
ISBN : 9789280523089

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Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by World Intellectual Property Organization Pdf

This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

Author : World Health Organization
Publisher : World Health Organization
Page : 147 pages
File Size : 47,8 Mb
Release : 2010
Category : Medical
ISBN : 9789241564045

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Medical Devices by World Health Organization Pdf

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 318 pages
File Size : 47,9 Mb
Release : 2011-10-25
Category : Medical
ISBN : 9780309212458

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Medical Devices and the Public's Health by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

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 : Anonim
Publisher : Unknown
Page : 372 pages
File Size : 53,7 Mb
Release : 1995
Category : Medical laws and legislation, International
ISBN : MINN:31951P004445427

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International Digest of Health Legislation by Anonim Pdf

Author : Anonim
Publisher : Unknown
Page : 1128 pages
File Size : 49,9 Mb
Release : 1994
Category : Law
ISBN : STANFORD:36105062054460

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European Legal Book Index by Anonim Pdf

Author : David Orentlicher,Tamara K. Hervey
Publisher : Oxford University Press
Page : 1135 pages
File Size : 55,7 Mb
Release : 2021-08-26
Category : Law
ISBN : 9780190846770

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The Oxford Handbook of Comparative Health Law by David Orentlicher,Tamara K. Hervey Pdf

The Oxford Handbook of Comparative Health Law addresses some of the most critical issues facing scholars, legislators, and judges today: how to protect against threats to public health that can quickly cross national borders, how to ensure access to affordable health care, and how to regulate the pharmaceutical industry, among many others. When matters of life and death literally hang in the balance, it is especially important for policymakers to get things right, and the making of policy can be greatly enhanced by learning from the successes and failures of approaches taken in other countries. Where there are "common challenges" in law and health, there is much to be gained from experiences elsewhere. Thus, for example, countries that suffered early from the COVID-19 pandemic provided valuable lessons about public health interventions for countries that were hit later. Accordingly, the Handbook considers key health law questions from a comparative perspective. In health law, common challenges are frequent. In addition to ones already mentioned, there are questions about addressing the social determinants of health (e.g., poverty and pollution), organizing health systems to optimize use of available resources, ensuring that physicians provide care of the highest quality, protecting patient privacy in a data-driven world, and properly balancing patient autonomy with the interest in preserving life when reproductive and end-of-life decisions are made. This Handbook's wide scope and comparative take on health law are particularly timely. Economic globalization has made it increasingly important for different countries to harmonize their legal rules. Students, practitioners, scholars, and policymakers need to understand how health laws vary across national boundaries and how reforms can ensure a convergence toward an optimal set of legal rules, or ensure that specific legal arrangements are needed in particular contexts. Indeed, comparative analysis has become essential for legal scholars, and The Oxford Handbook of Comparative Health Law is the only resource that provides such an analysis in health law.

Author : Anonim
Publisher : Unknown
Page : 456 pages
File Size : 45,9 Mb
Release : 1995
Category : Bibliography
ISBN : IND:30000045244005

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Current Publications in Legal and Related Fields by Anonim Pdf