title: Germany's competent authority initiatives.
abstract: A decentralised approach on the enforcement's' responsibility of the medical devices act, which includes the directives and the guidelines for the vigilance system, has been adopted in Germany. DIMDI under this act, had been nominated to set up a database-supported information system, that would ensure secure usage of medical devices in Germany. The necessary measures taken in order to fulfil the German legislation as well as DIMDI's points of view for the international data exchange on medical devices are being discussed in this paper.
authors.affiliation: German Institute for Medical Documentation and Information (DIMDI) Köln, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Stober
mesh_terms: D004864:Equipment and Supplies / Q000592:standards; D005858:Germany; D017408:Guidelines as Topic; D007256:Information Systems; D007883:Legislation, Medical; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards