Les Impacts De La Directive 2007 47 Ce Pour Les Entreprises Du Dispositif Medical

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Les impacts de la directive 2007/47/CE pour les entreprises du dispositif médical

Author : Alan Guivarc'h
Publisher :
ISBN 13 :
Total Pages : 262 pages
Book Rating : 4.:/5 (8 download)

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Book Synopsis Les impacts de la directive 2007/47/CE pour les entreprises du dispositif médical by : Alan Guivarc'h

Download or read book Les impacts de la directive 2007/47/CE pour les entreprises du dispositif médical written by Alan Guivarc'h and published by . This book was released on 2011 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: Avant Mars 2010, le marché des dispositifs médicaux s'appuyait sur un cadre européen régi par trois directives dites de la « nouvelle approche »: directive 90/385/CE relative aux dispositifs médicaux implantables actifs, directive 93/42/CEE relative aux dispositifs médicaux et directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro. Depuis le 21 mars 2010, une nouvelle directive, la directive 2007/47/CE modifiant les deux premiers textes cités, est entrée en application. Elle prend en compte l'expérience acquise depuis l'application de la directive 93/42/CEE et vise à renforcer la sécurité du patient, de l'utilisateur mais également de l'environnement. C'est dans ce but que l'évaluation clinique, via la conduite d'essais cliniques ou l'évaluation de la littérature scientifique, devient applicable à l'ensemble des dispositifs médicaux, indépendamment de leurs classes. Cependant, la directive 2007/47/CE n'apportant que peu de précisions sur les requis en vigilance.

Entrée en vigueur de la directive 2007/47/CE

Author : Maud Foglietti
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (866 download)

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Book Synopsis Entrée en vigueur de la directive 2007/47/CE by : Maud Foglietti

Download or read book Entrée en vigueur de la directive 2007/47/CE written by Maud Foglietti and published by . This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dans un souci de santé publique, tous les produits de santé doivent remplir certaines exigences pour pouvoir être mis sur le marché. Ces exigences ont été regroupées par les autorités de santé dans des textes règlementaires nationaux et européens, qui ont petit à petit donné naissance à différents statuts juridiques. Les premiers textes réglementaires concernant les dispositifs médicaux sont apparus au cours des années 1990. La dernière évolution de ces référentiels date de 2007, avec la Directive 2007/47/CE. Celle-ci apporte des modifications notamment en matière d'évaluation clinique des dispositifs médicaux. L'aspect clinique repose désormais sur l'évaluation du rapport bénéfice / risque dans les conditions d'utilisation définies par le fabricant. Ce rapport doit être positif pour qu'un produit de santé soit utilisable. Le présent travail décrit la mise en place d'un processus évaluation clinique au sein d'une entreprise fabricant des dispositifs médicaux dans le but de répondre aux exigences de la Directive 2007/47/CE en termes d'évaluation clinique.

Impacts de la mise en place de la directive 2007/47/CE sur l'évaluation clinique des dispositifs médicaux

Author : Thomas Martin
Publisher :
ISBN 13 :
Total Pages : 220 pages
Book Rating : 4.:/5 (758 download)

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Book Synopsis Impacts de la mise en place de la directive 2007/47/CE sur l'évaluation clinique des dispositifs médicaux by : Thomas Martin

Download or read book Impacts de la mise en place de la directive 2007/47/CE sur l'évaluation clinique des dispositifs médicaux written by Thomas Martin and published by . This book was released on 2010 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: Les dispositifs médicaux représentent un ensemble très hétéroclite de produits et leur règlementation est particulièrement complexe et en pleine évolution ces dernières années. Une évolution majeure a pris effet au 21 mars de cette année 2010 avec la mise en application de la nouvelle directive européenne 2007/47/CE qui vient amender les différentes directives jusqu'alors en vigueur. L'objectif de ce travail était de montrer les différents impacts de cette nouvelle directive sur l'évaluation clinique des dispositifs médicaux. Nous détaillerons tout d'abord le contexte qui est celui du secteur des DM puis nous verrons ensuite dans une seconde partie, transition indispensable à la compréhension de notre problématique, les différents processus d'interprétation de la législation. Nous décrirons ainsi les différents outils actuellement à la disposition des fabricants des gap analysis aux différents guides d'interprétation (GHTF et MEDDEV) pour aboutir à la rédaction des procédures internes. Enfin, nous détaillerons les différents impacts concernant d'une part la conduite d'investigations cliniques (caractère obligatoire pour les DM à plus fort niveau de risque, rôle du comité d'éthique, procédure en cas d'arrêt prématuré des études et gestion des événements indésirables) et d'autre part l'amélioration des procédés concernant le recours à la revue de la littérature. Nous verrons ainsi en quoi cette nouvelle directive européenne constitue une évolution majeure dans l'évaluation clinique des DM au sein d'une démarche globale amorcée à l'aube des années 90 avec la mise en place des premières directives européennes encadrant ce secteur d'activité.

L'Accès au marché européen des dispositifs médicaux combinés

Author : Vlora Nishevci
Publisher :
ISBN 13 :
Total Pages : 44 pages
Book Rating : 4.:/5 (899 download)

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Book Synopsis L'Accès au marché européen des dispositifs médicaux combinés by : Vlora Nishevci

Download or read book L'Accès au marché européen des dispositifs médicaux combinés written by Vlora Nishevci and published by . This book was released on 2014 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: La réglementation européenne, notamment la directive 93/42/CEE modifiée par la directive 2007/47/CE, prévoit la procédure d’enregistrement des dispositifs médicaux, notamment du dispositif médical combiné en Europe. C’est donc l’apposition du marquage CE qui permet l’accès au marché européen, et afin d’obtenir ce marquage, de nombreuse données, telles que le dossier technique, les normes applicables, le dossier de gestion des risques, sont exigées. Ces données doivent assurer la qualité, la sécurité et l’efficacité du produit. Seulement, ce marquage n’est pas toujours suffisant pour accéder au marché. En effet, le fabricant peut souhaiter le remboursement de son produit par les organismes de protection sociale. En comparant différents systèmes de remboursement et d’évaluation des prix des dispositifs médicaux de trois pays de l’Union Européenne, seront définis les critères permettant l’avis favorable des autorités de santé par un remboursement. C’est l’innovation présentée par le dispositif médical combiné qui assurera l’accès au marché européen.

Évolution du cadre juridique de la mise sur le marché des dispositifs médicaux dans l'Union Européenne

Author : Célia Chadirac
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (9 download)

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Book Synopsis Évolution du cadre juridique de la mise sur le marché des dispositifs médicaux dans l'Union Européenne by : Célia Chadirac

Download or read book Évolution du cadre juridique de la mise sur le marché des dispositifs médicaux dans l'Union Européenne written by Célia Chadirac and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: L'objectif de cette thèse est de faire un état des lieux de la règlementation des dispositifs médicaux en France et dans l'Union Européenne et d'analyser ses évolutions pour permettre d'illustrer les apports du futur règlement et de souligner son impact prévisible. Le cadre juridique initial de la mise sur le marché des dispositifs médicaux est posé par la directive 93/42/CEE. Pour être mis sur le marché, un dispositif médical doit obtenir le marquage CE qui garantit la conformité aux exigences essentielles de l'annexe I, la procédure d'évaluation de la conformité dépendant de la classe de risque du dispositif. Malgré les apports de la directive 2007/47/CE, concernant notamment l'évaluation clinique et la surveillance après commercialisation, la Commission européenne a considéré que la réglementation des dispositifs médicaux devait être profondément révisée. L'objectif de la refonte de ces directives est d'obtenir un cadre règlementaire simplifié, favorable à l'innovation et la compétitivité, et assurant un niveau élevé de sécurité. Cela a conduit en 2012 à la publication de la proposition de règlement du Parlement européen et du Conseil sur les dispositifs médicaux. les principales mesures sont la mise en place d'une procédure d'évaluation conjointe des organismes notifiées, un meilleur encadrement des investigations cliniques, la création d'une base de données européenne pour la vigilance et la surveillance du marché, une définition des rôles et obligations des opérateurs économiques, la création du GCDM et la mise en place d'un système d'identifiant unique européen. Ce règlement entrainera un bouleversement majeur, mais nécessaire, du marché des dispositifs médicaux impactant les opérateurs économiques, les organismes notifiés et les autorités compétentes pour une meilleure sécurité des patients.

Directive européenne 93/42/CEE du Conseil modifiée par la directive européenne 2007/47/CE du Parlement européen et du Conseil du 5 septembre 2007 relative aux dispositifs médicaux

Download Directive européenne 93/42/CEE du Conseil modifiée par la directive européenne 2007/47/CE du Parlement européen et du Conseil du 5 septembre 2007 relative aux dispositifs médicaux PDF Online Free

Author : Sandrine Beauvis
Publisher :
ISBN 13 :
Total Pages : 194 pages
Book Rating : 4.:/5 (494 download)

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Book Synopsis Directive européenne 93/42/CEE du Conseil modifiée par la directive européenne 2007/47/CE du Parlement européen et du Conseil du 5 septembre 2007 relative aux dispositifs médicaux by : Sandrine Beauvis

Download or read book Directive européenne 93/42/CEE du Conseil modifiée par la directive européenne 2007/47/CE du Parlement européen et du Conseil du 5 septembre 2007 relative aux dispositifs médicaux written by Sandrine Beauvis and published by . This book was released on 2008 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt:

For a meaningful artificial intelligence

Author : Cédric Villani
Publisher : Conseil national du numérique
ISBN 13 :
Total Pages : 154 pages
Book Rating : 4./5 ( download)

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Book Synopsis For a meaningful artificial intelligence by : Cédric Villani

Download or read book For a meaningful artificial intelligence written by Cédric Villani and published by Conseil national du numérique. This book was released on 2018-03-28 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Togo

Author : International Monetary Fund. African Dept.
Publisher : International Monetary Fund
ISBN 13 : 1498332404
Total Pages : 201 pages
Book Rating : 4.4/5 (983 download)

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Book Synopsis Togo by : International Monetary Fund. African Dept.

Download or read book Togo written by International Monetary Fund. African Dept. and published by International Monetary Fund. This book was released on 2014-07-23 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Poverty Reduction Strategy Paper highlights that Togo’s Strategy for Boosting Growth and Promoting Employment offers a medium-term development framework for implementing the Government’s General Policy Statement, the Millennium Development Goals, and the Government’s vision for making Togo an emerging economy in 15 to 20 years, as well as making it a country that respects human rights and promotes the rule of law. The return of political stability and peace to the country created a favorable environment for better governance, resumption of international assistance, and significant reduction in exterior public debt. The Government’s medium-term economic policy for 2013–2017 will essentially be used to build and consolidate the foundations for Togo’s future economic emergence. The focus will be on new priorities: boosting growth; employment and inclusion; strengthening governance; and reducing regional disparities and promoting grassroots development. Designing a national land-use plan will territorialize development by creating a more balanced national economic space. The new land-use scheme will be based on dynamic, competitive, regional economies in which the urbanization of regional capitals and secondary towns is sufficiently controlled to allow true development hubs to emerge.

The Radiological Accident in Goiânia

Author : International Atomic Energy Agency
Publisher :
ISBN 13 :
Total Pages : 174 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Radiological Accident in Goiânia by : International Atomic Energy Agency

Download or read book The Radiological Accident in Goiânia written by International Atomic Energy Agency and published by . This book was released on 1988 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Government and authorities in Brazil were faced with a tragic accident in Goiânia resulting from the misuse of a strongly radioactive medical teletherapy source not under radiation protection surveillance. The present report is divided into four parts: a chronology of destruction of the source, discovery of the accident and initial response; a description of the human consequences and the dosimetry and treatment of seriously exposed and contaminated persons; an account of the assessment of the environmental contamination and the remedial actions taken; and observations and recommendations. Appendices and annexes give an assessment of the effectiveness of international co-operation in the emergency response, and provide further information on: public communications; radiological survey equipment; guidelines for the discharge of patients; radiological protection; chemical decontamination; and the lessons learned.

Labour Rights as Human Rights

Author : Philip Alston
Publisher : Collected Courses of the Acade
ISBN 13 :
Total Pages : 272 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Labour Rights as Human Rights by : Philip Alston

Download or read book Labour Rights as Human Rights written by Philip Alston and published by Collected Courses of the Acade. This book was released on 2005 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Are efforts to protect workers' rights compatible with the forces of globalization? How can minimum standards designed to protect labour rights be implemented in a world in which national labour law is more and more at the mercy of international forces beyond its control? And does it makeany difference if we see rights such as the right to freedom of association, to non-discrimination in the workplace, to freedom from child labour, and to safe and healthy working conditions in terms of international human rights law? Or are they more appropriately seen as 'principles' to bepromoted as and where appropriate?The contributors to this volume argue that international agreements and institutions are of central importance if labour rights are to be protected in a globalized economy. But the report cards they give to the World Trade Organization, the European Union, NAFTA, and the Free Trade Agreement of theAmericas are generally very critical. While there is a strong rhetorical commitment to labour rights, at least on the part of the US and the EU, the substance of what has been achieved to date is hardly impressive. The role of the International Labour Organization is central and the authorsexplore some of the options that are open to governments, civil society, and the labour movement in the years ahead.

Extended Producer Responsibility A Guidance Manual for Governments

Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264189866
Total Pages : 159 pages
Book Rating : 4.2/5 (641 download)

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Book Synopsis Extended Producer Responsibility A Guidance Manual for Governments by : OECD

Download or read book Extended Producer Responsibility A Guidance Manual for Governments written by OECD and published by OECD Publishing. This book was released on 2001-03-20 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance manual presents the potential benefits and costs associated with Extended Producer Responsibility.

The Patient Will See You Now

Author : Eric Topol
Publisher : Basic Books
ISBN 13 : 0465094473
Total Pages : 386 pages
Book Rating : 4.4/5 (65 download)

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Book Synopsis The Patient Will See You Now by : Eric Topol

Download or read book The Patient Will See You Now written by Eric Topol and published by Basic Books. This book was released on 2016-10-25 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: The essential guide by one of America's leading doctors to how digital technology enables all of us to take charge of our health A trip to the doctor is almost a guarantee of misery. You'll make an appointment months in advance. You'll probably wait for several hours until you hear "the doctor will see you now"-but only for fifteen minutes! Then you'll wait even longer for lab tests, the results of which you'll likely never see, unless they indicate further (and more invasive) tests, most of which will probably prove unnecessary (much like physicals themselves). And your bill will be astronomical. In The Patient Will See You Now, Eric Topol, one of the nation's top physicians, shows why medicine does not have to be that way. Instead, you could use your smartphone to get rapid test results from one drop of blood, monitor your vital signs both day and night, and use an artificially intelligent algorithm to receive a diagnosis without having to see a doctor, all at a small fraction of the cost imposed by our modern healthcare system. The change is powered by what Topol calls medicine's "Gutenberg moment." Much as the printing press took learning out of the hands of a priestly class, the mobile internet is doing the same for medicine, giving us unprecedented control over our healthcare. With smartphones in hand, we are no longer beholden to an impersonal and paternalistic system in which "doctor knows best." Medicine has been digitized, Topol argues; now it will be democratized. Computers will replace physicians for many diagnostic tasks, citizen science will give rise to citizen medicine, and enormous data sets will give us new means to attack conditions that have long been incurable. Massive, open, online medicine, where diagnostics are done by Facebook-like comparisons of medical profiles, will enable real-time, real-world research on massive populations. There's no doubt the path forward will be complicated: the medical establishment will resist these changes, and digitized medicine inevitably raises serious issues surrounding privacy. Nevertheless, the result-better, cheaper, and more human health care-will be worth it. Provocative and engrossing, The Patient Will See You Now is essential reading for anyone who thinks they deserve better health care. That is, for all of us.

The European Observatory for SMEs

Author : European Observatory for SMEs
Publisher :
ISBN 13 :
Total Pages : 444 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The European Observatory for SMEs by : European Observatory for SMEs

Download or read book The European Observatory for SMEs written by European Observatory for SMEs and published by . This book was released on 2000 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: Against the background of completing the European Single Market is the observance and monitoring of small and medium-sized enterprises (SMEs). With about 20 million such businesses, employing some 117 million people, SMEs represent an economic lynchpin to the success of the Single Market concept. This 6th report, from the Observatory, and prepared by a consortium led by KPMG Consulting, focuses on the economic and financial needs of SMEs. Specific chapters look at their products and services, the recruitment and training of staff, particulary vocational training, and their access to investment. The report is concluded with the set of policy recommendations, which are aimed at strengthening the entrepreneurial culture. These recommendations include: to provide more information on public procurement to SMEs; to promote further resarch on the impact of electronic commerce on the position of SMEs.

Treaty Series / Recueil Des Traites

Author : United Nations
Publisher : UN
ISBN 13 : 9789219003019
Total Pages : 480 pages
Book Rating : 4.0/5 (3 download)

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Book Synopsis Treaty Series / Recueil Des Traites by : United Nations

Download or read book Treaty Series / Recueil Des Traites written by United Nations and published by UN. This book was released on 2007-11-02 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Civic Education Across Countries

Author : Judith Torney-Purta
Publisher :
ISBN 13 :
Total Pages : 626 pages
Book Rating : 4.4/5 (91 download)

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Book Synopsis Civic Education Across Countries by : Judith Torney-Purta

Download or read book Civic Education Across Countries written by Judith Torney-Purta and published by . This book was released on 1999 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt: Kerry Kennedy and John Hughes

Open Content Licensing

Author : Lucie Guibault
Publisher : Amsterdam University Press
ISBN 13 : 9089643079
Total Pages : 296 pages
Book Rating : 4.0/5 (896 download)

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Book Synopsis Open Content Licensing by : Lucie Guibault

Download or read book Open Content Licensing written by Lucie Guibault and published by Amsterdam University Press. This book was released on 2011 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although open content licenses only account for a fraction of all copyright licenses currently enforced in the world, their introduction has had profound effects on the use and dissemination of information. This book explores the theoretical underpinnings of these licenses and offers insight on the practical advantages and inconveniences of their use. The essays collected here include an objective study of the principles of open content from the perspective of European intellectual property law as well as novel examinations of their possible implementation in different areas of the cultural or information industry.

Global Economic Prospects, January 2021

Author : World Bank Group
Publisher : World Bank Publications
ISBN 13 : 1464816131
Total Pages : 412 pages
Book Rating : 4.4/5 (648 download)

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Book Synopsis Global Economic Prospects, January 2021 by : World Bank Group

Download or read book Global Economic Prospects, January 2021 written by World Bank Group and published by World Bank Publications. This book was released on 2021-03-23 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although the global economy is emerging from the collapse triggered by COVID-19, the recovery is likely to be subdued, and global GDP is projected to remain well below its pre-pandemic trend for a prolonged period. Several risks cloud the outlook, including those related to the pandemic and to rapidly rising debt. The pandemic has further diminished already-weak growth prospects for the next decade. Decisive policy actions will be critical in raising the likelihood of better growth outcomes while warding off worse ones. Immediate priorities include supporting vulnerable groups and ensuring a prompt and widespread vaccination process to bring the pandemic under control. Although macroeconomic policy support will continue to be important, limited fiscal policy space amid high debt highlights the need for an ambitious reform agenda that bolsters growth prospects. To address many of these challenges, global cooperation will be key. Global Economic Prospects is a World Bank Group Flagship Report that examines global economic developments and prospects, with a special focus on emerging market and developing economies, on a semiannual basis (in January and June). The January edition includes in-depth analyses of topical policy challenges faced by these economies, while the June edition contains shorter analytical pieces.