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

Fraser, Alan Gordon, Daubert, J.-C., Van de Werf, F., Estes, N. A. M., Smith, S. C., Krucoff, M. W., Vardas, P. E., Komajda, M., Anker, S., Auricchio, A., Bailey, S., Bonhoeffer, P., Borggrefe, M., Brodin, L.-A., Bruining, N., Buser, P., Butchart, E., Calle Gordo, J., Cleland, J., Danchin, N., Daubert, J., Degertekin, M., Demade, I., Denjoy, N., Derumeaux, G., Di Mario, C., Dickstein, K., Dudek, D., Estes, N., Farb, A., Flotats, A., Fraser, A., Gueret, P., Israel, C., James, S., Kautzner, J., Komajda, M., Krucoff, M., Lombardi, M., Marwick, T., Mioulet, M., O'Kelly, S., Perrone-Filardi, P., Rosano, G., Rosenhek, R., Sabate, M., Smith, S., Swahn, E., Tavazzi, L., Van de Werf, F., van der Velde, E., van Herwerden, L., Vardas, P., Voigt, J.-U., Weaver, D. and Wilmshurst, P. 2011. Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform: report of a policy conference of the European Society of Cardiology. European Heart Journal 32 (13) , pp. 1673-1686. 10.1093/eurheartj/ehr171

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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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Subjects:	R Medicine > R Medicine (General) T Technology > T Technology (General)
Uncontrolled Keywords:	Medical devices; European device directives; recast of legislation; premarket approval; post-marketing surveillance
Publisher:	Oxford University Press
ISSN:	0195-668X
Last Modified:	04 Jun 2017 03:48
URI:	https://orca.cardiff.ac.uk/id/eprint/27241

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