Eine Zulassung von Medizinprodukten durch staatliche Stellen bringt keinen Sicherheitsgewinn und verlangsamt den Patientenzugang zu Medizinprodukten. Das betonte BVMed-Geschäftsführer und Vorstandsmitglied Joachim M. Schmitt in einer Stellungnahme zur morgigen (27. Juni 2012) Anhörung im Bundestags-Gesundheitsausschuss zur Sicherheit von Medizinprodukten. "Beim PIP-Skandal um fehlerhafte Brustimplantate handelte es sich nicht um ein Zulassungs-, sondern um ein Überwachungsproblem. Wir sollten deshalb das Vollzugsdefizit durch bessere Kontrollen und verbesserte Koordination der Überwachungstätigkeit beseitigen, aber an den bewährten Marktzulassungsregelungen für Medizinprodukte festhalten", so Schmitt.
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Ccmlafiosd Ynvbes dgwve: zihx://pei.yvsya.pp/rtxjvs.kci?69401
