European Medical Device Regulation Mdr For Medtech And Medical Device Manufacturers

Author : Des O'Brien
Publisher : Unknown
Page : 127 pages
File Size : 43,5 Mb
Release : 2019-04-05
Category : Electronic
ISBN : 1092813519

Get Book

European Medical Device Regulation (MDR) for MedTech and Medical Device Manufacturers by Des O'Brien Pdf

The new European regulations on medical devices and in vitro medical devices were adopted on 05 April 2017 and came into force on 25th May 2017. Both these 2 new regulations replace and repeal Council Directives 90/385/EEC, 93/42/EEC Directive 98/79/EC and Commission Decision 2010/227/EU. This short book (approx 120 pages) provides a foundation overview of the new regulations and how they are structured. It must be stated that many notified bodies and companies provide insight and guidance online, this book provides a tangible resource for day to day use or for gaining an introduction to EU MDR, or alternatively as an ongoing quick reference guide. Although adopted and in force, the new rules shall only apply after a 3-year transitional period, whereby regulations will enter into force in April 2020 for medical devices and for five years after entry into force (April 2022) for the Regulation on in-vitro diagnostic medical devices.

Author : G.R Higson
Publisher : CRC Press
Page : 192 pages
File Size : 40,7 Mb
Release : 2001-10-29
Category : Medical
ISBN : 9781040053935

Get Book

Medical Device Safety by G.R Higson Pdf

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

Author : Christa Altenstetter
Publisher : Routledge
Page : 277 pages
File Size : 51,6 Mb
Release : 2017-09-08
Category : Medical
ISBN : 9781351506281

Get Book

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 : Prakash Srinivasan Timiri Shanmugam,Pugazhenthan Thangaraju,Nandakumar Palani,Thamizharasan Sampath
Publisher : Springer Nature
Page : 382 pages
File Size : 48,9 Mb
Release : 2022-04-22
Category : Technology & Engineering
ISBN : 9783030918552

Get Book

Medical Device Guidelines and Regulations Handbook by Prakash Srinivasan Timiri Shanmugam,Pugazhenthan Thangaraju,Nandakumar Palani,Thamizharasan Sampath Pdf

This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field; Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR; Presents simplified guidelines and regulation points.

Author : Dirk Lanzerath,Sebastian Graf von Kielmansegg,Joerg Hasford
Publisher : Unknown
Page : 168 pages
File Size : 48,9 Mb
Release : 2020
Category : Medical instruments and apparatus
ISBN : 9783643962607

Get Book

The Development of Medical Devices by Dirk Lanzerath,Sebastian Graf von Kielmansegg,Joerg Hasford Pdf

Author : Christian Baumgartner,Johann Harer,Jörg Schröttner
Publisher : Springer Nature
Page : 671 pages
File Size : 54,6 Mb
Release : 2023-08-26
Category : Technology & Engineering
ISBN : 9783031220913

Get Book

Medical Devices and In Vitro Diagnostics by Christian Baumgartner,Johann Harer,Jörg Schröttner Pdf

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 : Richard C. Fries
Publisher : CRC Press
Page : 490 pages
File Size : 46,5 Mb
Release : 2005-11-21
Category : Medical
ISBN : 9781420027945

Get Book

Reliable Design of Medical Devices by Richard C. Fries Pdf

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Author : United States. General Accounting Office
Publisher : Unknown
Page : 52 pages
File Size : 46,6 Mb
Release : 1996
Category : Medical instruments and apparatus
ISBN : UOM:39015048858008

Get Book

Medical Device Regulation by United States. General Accounting Office Pdf

Author : Shalinee Naidoo
Publisher : Arcler Press
Page : 128 pages
File Size : 48,6 Mb
Release : 2020-11
Category : Electronic
ISBN : 1774078082

Get Book

Medical Device Regulations: Transitioning from MDD 93/42/EEC to MDR 2017/745 by Shalinee Naidoo Pdf

In recent times the need for improving regulatory controls and finding ways to improve the quality and access to safe medical devices has increased. The Medical Devices Directive 93/42/EEC was enforced to provide a harmonised regulatory environment for all medical devices sold within the European Union however new and emerging technologies as well as various well-known incidents within the medical device industry have challenged the current framework and highlighted gaps and a scarcity of skills and expertise. For this reason, there has been an increasing need to update the MDD which led to the development and release of the Medical Device Regulation (EU MDR 2017/745). This has since marked the start of a three-year transition period for manufacturers, suppliers, Notified Bodies, and National Competent Authorities. While compliance to the new regulation was set to take effect in May of 2020, it has now been postponed by a year due to the recent coronavirus pandemic. This has essentially given manufacturers more time to assess their overall readiness and reprioritize the time-consuming areas of the transition. This volume aims to provide an easy-to-understand guide for beginners to the medical device regulations in Europe and looks specifically at the changes between the current Medical Device Directive 93/42/EEC and forthcoming Medical Devices Regulation (EU MDR 2017/745) with regards to classification, conformity assessments and assessing general safety and performance requirements.

Author : Michael Cheng,World Health Organization
Publisher : Diamond Pocket Books (P) Ltd.
Page : 58 pages
File Size : 45,9 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9241546182

Get Book

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 : Almir Badnjević,Mario Cifrek,Ratko Magjarević,Zijad Džemić
Publisher : Springer Nature
Page : 441 pages
File Size : 42,9 Mb
Release : 2023-12-28
Category : Technology & Engineering
ISBN : 9783031434440

Get Book

Inspection of Medical Devices by Almir Badnjević,Mario Cifrek,Ratko Magjarević,Zijad Džemić Pdf

This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!

Author : Nupur Chowdhury
Publisher : Springer Science & Business
Page : 190 pages
File Size : 42,5 Mb
Release : 2014-04-29
Category : Law
ISBN : 9783319045948

Get Book

European Regulation of Medical Devices and Pharmaceuticals by Nupur Chowdhury Pdf

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.

Author : Wolfgang Ecker
Publisher : BoD – Books on Demand
Page : 346 pages
File Size : 46,7 Mb
Release : 2022-03-25
Category : Law
ISBN : 9783754384848

Get Book

Medical Devices and IVDs by Wolfgang Ecker Pdf

With this book, you get a really complete seminar for the new Regulations on medical devices and IVDs in the EU, ready at hand, at any time. These EU regulations create new rules for medical technology and laboratory diagnostics in Europe. Concise regulatory know-how is now required to keep or reposition medical devices and in vitro diagnostics on the European market, from syringes, contact lenses, medical device apps, pregnancy tests, nuclear magnetic resonance tomography to cancer tests, genetic diagnostics, HIV tests, hip implants, heart catheters, artificial spinal discs, stents and pacemakers. Concise regulatory training and further education of employees in companies and health care facilities is the order of the day. This also applies to biomedical and medical technology students at universities of applied sciences and biomedical universities, start-ups and spin-offs, who must make use of this know-how from the initial product idea through the further stages of product development to market access. The book provides a thorough, compact course on the new regulations, starting with perfect overview and easy navigation and going into depth where you need it: this book will make you fit and confident for the new European challenges!

Author : Shalinee Naidoo
Publisher : Arcler Press
Page : 0 pages
File Size : 40,9 Mb
Release : 2022-12
Category : Electronic
ISBN : 1774694115

Get Book

The Medical Device Handbook for Europe by Shalinee Naidoo Pdf

As the medical device landscape continues to evolve, so does the regulatory framework in Europe. Through this process many gaps and scarcity of skills and expertise have also been identified. For this reason, there was an increasing need to update the current medical device directive (MDD 93/42/EEC) being used within the European Union. This in turn led to the development and release of the Medical Device Regulation (EU MDR 2017/745). The release of the new Medical Device Regulation (EU MDR 2017/745) in 2017 marked the start of a three-year transition period for various Economic Operators along the supply chain. This volume aims to provide a simple overview of the medical device industry in Europe with particular focus on the main aspects covered in the new European Medical Device Regulation. Important concepts such as essential phases in a device lifecycle, complying to standards and regulations, the CE mark process and classification of medical devices in Europe are covered.

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 : 50,7 Mb
Release : 2011-10-25
Category : Medical
ISBN : 9780309212458

Get Book

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.