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Eur J Cardiothorac Surg 2006;6:S102-S106
© 2006 Elsevier Science NL

New developments in clinical testing of medical devices for Europe 1992

Department of Physiology, Cardiovascular Research Institute Maastricht, University of Limburg, Maastricht, The Netherlands

The unification of Europe is associated with the introduction of many new regulations aiming at, for example, standardization and quality control. Several of these generally normative regulations are pertinent to clinical investigations of medical devices, such as heart valves, pacemakers and cardiac assist devices. Relevant documents dealing with these regulations are the "Guidance for good clinical practice for trials on medicinal products in the European Community," a standard already passed by the European Parliament, and CEN (Comité Européen de Normalisation) document TC258 dealing with "Clinical investigations of medical devices". The latter standard is in discussion among member states of the European Community. In this present survey the most important issues dealt with in these documents will be summarized with emphasis on the aspects relevant to clinical investigations of medical devices.

Key Words: Good clinical practice • Medical devices • European standards • Role of clinical investigator • Audits • Ethics Committee