Factsheet for Authorities in Non-EU/EEA States on Medical Devices and in Vitro Diagnostic Medical Devices PDF Download
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Author:
Publisher:
ISBN: 9789279904059
Category :
Languages : en
Pages :
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Book Description
The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulations, (EU) 2017/746 (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making. The new Regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, which improves clinical safety and creates fair market access for manufacturers. In contrast to Directives, Regulations are directly applicable and do not need to be transposed into national law. The MDR and the IVDR will therefore reduce the risks of discrepancies in interpretation across the EU market.
Author:
Publisher:
ISBN: 9789279904059
Category :
Languages : en
Pages :
Get Book Here
Book Description
The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulations, (EU) 2017/746 (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making. The new Regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, which improves clinical safety and creates fair market access for manufacturers. In contrast to Directives, Regulations are directly applicable and do not need to be transposed into national law. The MDR and the IVDR will therefore reduce the risks of discrepancies in interpretation across the EU market.
Author:
Publisher: Global Regulatory Press
ISBN: 1903757037
Category :
Languages : en
Pages : 9
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Book Description
Author: Christian Baumgartner
Publisher: Springer Nature
ISBN: 3031220919
Category : Technology & Engineering
Languages : en
Pages : 671
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Book Description
This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries.
Author:
Publisher:
ISBN: 9789279897023
Category :
Languages : en
Pages :
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Book Description
This Factsheet is aimed at manufacturers of medical devices. For a general overview of the impact of the In Vitro Medical Devices Regulation (IVDR) on manufacturers see the Factsheet for manufacturers of in vitro diagnostic medical devices. References to Annexes and Articles in this factsheet refer to the MDR (2017/745/EU).
Author: Bernhard M. Maassen
Publisher: Springer Science & Business Media
ISBN: 9401583196
Category : Law
Languages : en
Pages : 130
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Book Description
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: United States. Bureau of Medical Devices and Diagnostic Products
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 24
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Book Description
Author:
Publisher:
ISBN: 9789279897078
Category :
Languages : en
Pages :
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Book Description
The new Medical Devices Regulation (2017/745/ EU) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making. The new Regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers. In contrast to Directives, Regulations do not need to be transposed into national law. The MDR and the IVDR will therefore reduce the risks of discrepancies in interpretation across the EU market. Transitional periods are planned to smooth the application of the new Regulations. However, you should bear in mind that consultants, in-house professionals, and Notified Bodies will all get busier as the deadline draws closer.
Author: United States. Bureau of Medical Devices
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 68
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Book Description
Author: Christa Altenstetter
Publisher: Routledge
ISBN: 1351506285
Category : Medical
Languages : en
Pages : 277
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Book Description
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: Jack Wong
Publisher: CRC Press
ISBN: 1000440532
Category : Medical
Languages : en
Pages : 620
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Book Description
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
