title: German law: the differences.
abstract: Medical device regulations in Germany are changing. The first amendment of the Medical Device Law, the MPG, is in preparation. Four decrees on medical devices are also being discussed by the Bundesrat, the Federal Council. This article summarizes what manufacturers, distributors and users should know about the German device regulations.
authors.affiliation: Müller-Lierheim Group, Munich, Germany.
authors.forename: W G
authors.initials: WG
authors.lastname: Müller-Lierheim
mesh_terms: D002986:Clinical Trials as Topic; D004869:Equipment Safety / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards; D005858:Germany; D006801:Humans; D016365:Liability, Legal; D008283:Maintenance / Q000592:standards; D013677:Medical Laboratory Science / Q000331:legislation & jurisprudence*; D015337:Multicenter Studies as Topic; D011358:Product Surveillance, Postmarketing