title: [Regulatory aspects of clinical trials for medical devices and in vitro diagnostics].
abstract: The European Medical Device Directives and In Vitro Diagnostic Directive were transposed into the German Medical Device Law (MPG) in 2002. Clinical trials in Germany are to be conducted in accordance with the MPG, Harmonized European Standards, professional codes and laws and for medical and scientific reasons according to ICH GCP.
authors.affiliation: joachimschwarz.jas@web.de
authors.forename: J A
authors.initials: JA
authors.lastname: Schwarz
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D018795:Device Approval; D019937:Diagnostic Techniques and Procedures / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards; D017041:Ethics Committees; D005060:Europe; D005069:Evaluation Studies as Topic; D005858:Germany; D006801:Humans; D066298:In Vitro Techniques; D007258:Informed Consent; D010817:Physician-Patient Relations; D017410:Practice Guidelines as Topic; D018570:Risk Assessment; D013997:Time Factors