["Medical devices and European regulations"]

Abstract

In order to put on the European Market, the medical devices shall be in conformity with two European Directives transcribed in national regulation: Directive 90/385/CEE--20 June 1990: concerning the implantable active medical devices, mandatory since the 1/01/95; Directive 93/42/CEE--13 June 1993: concerning the medical devices, applicable since the 1/01/95 and mandatory the 14/06/98. Both impose the conformity to essential requirements which can be proved by different procedures of evaluation verified by notify bodies. Then, the CE mark, technical passport, can be apposed. To demonstrate this conformity, the manufacturers can use harmonized european standards without obligation. The "Safety clause" allows to follow the "well-founded" of the CE marking and the national systems of vigilance to register and evaluate the incidents and to define corrective actions.