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[Regulatory aspects of clinical trials for medical devices and in vitro diagnostics].

[Article in German]

Author information

1
joachimschwarz.jas@web.de

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.

PMID:
15887066
DOI:
10.1007/s00103-005-1036-3
[Indexed for MEDLINE]
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