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Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform: Report of a policy conference of the European Society of Cardiology

2011; Oxford University Press; Volume: 32; Issue: 13 Linguagem: Inglês

10.1093/eurheartj/ehr171

1522-9645

Alan G. Fraser, Jean Claude Daubert, Frans Van de Werf, N.A. Mark Estes, Sidney C. Smith, Mitchell W. Krucoff, Panos Vardas, Michel Komajda, S.D. Anker, Angelo Auricchio, Sarah Bailey, P. Bonhoeffer, Martin Borggrefe, L.‐Å. Brodin, Nico Bruining, Peter Buser, Eric G. Butchart, J. Calle Gordo, Jennifer Cleland, N Danchin, Jean Claude Daubert, M. Degertekin, I. Demade, N. Denjoy, Geneviève Dérumeaux, Carlo Di Mario, Kenneth Dickstein, Damian Dudek, Norman Estes, Andrew Farb, Albert Flotats, Alan G. Fraser, P. Gueret, Carsten W. Israel, Stefan James, Josef Kautzner, Michel Komajda, Mitchell W. Krucoff, Massimo Lombardi, Thomas H. Marwick, M. Mioulet, Sara Lupita O’Kelly, P. Perrone-Filardi, Giuseppe Rosano, Raphaël Rosenhek, Manel Sabaté, Sean J. Smith, Eva Swahn, Luigi Tavazzi, Frans Van de Werf, Enno T. van der Velde, Lex van Herwerden, Panos Vardas, Jens‐Uwe Voigt, David Weaver, Peter Wilmshurst,

Health Systems, Economic Evaluations, Quality of Life

The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.