title: Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.
abstract: 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.
authors.affiliation: Department of European Affairs, European Society of Cardiology, The European Heart House, 2035 Route des Colles-Les Templiers, Sophia Antipolis, France.
authors.forename: Alan G
authors.initials: AG
authors.lastname: Fraser
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Daubert
authors.forename: Frans
authors.initials: F
authors.lastname: Van de Werf
authors.forename: N A Mark
authors.initials: NA
authors.lastname: Estes
authors.forename: Sidney C
authors.initials: SC
authors.lastname: Smith
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
authors.forename: Panos E
authors.initials: PE
authors.lastname: Vardas
authors.forename: Michel
authors.initials: M
authors.lastname: Komajda
mesh_terms: D020811:Biomedical Technology / Q000331:legislation & jurisprudence / Q000592:standards; D002309:Cardiology / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D003952:Diagnostic Imaging / Q000295:instrumentation; D004059:Diffusion of Innovation; D004867:Equipment Design / Q000592:standards; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D019981:Health Care Sector / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007400:Interprofessional Relations; D007883:Legislation, Medical; D061214:Patient Safety; D014481:United States