Bundesgesetz, mit dem das Medizinproduktegesetz geändert wird
46. Bundesgesetz, mit dem das Medizinproduktegesetz geändert wird
Der Nationalrat hat beschlossen:
Das Medizinproduktegesetz (MPG), BGBl. Nr. 657/1996, zuletzt geändert durch das Bundesgesetz BGBl. I Nr. 23/2020, wird wie folgt geändert:
1. In § 4 Abs. 2 wird die Wortfolge ?BGBl. Nr. 194? durch die Wortfolge ?BGBl. Nr. 194/1994? ersetzt.
2. Nach § 113a wird folgender § 113b eingefügt:
?§ 113b.
Ergänzend zu § 113a Medizinproduktegesetz wird festgelegt, dass Schnelltests zum Nachweis eines Vorliegens einer Infektion mit SARS-CoV-2, die durch den Hersteller für eine Probennahme im anterior nasalen Bereich in Verkehr gebracht und mit einer CE-Kennzeichnung gemäß dem Medizinproduktegesetz oder auf der Grundlage der Richtlinie 98/79/EG ergangenen nationalen Vorschriften anderer Vertragsparteien des Abkommens über den Europäischen Wirtschaftsraum versehen sind, jedoch vom Hersteller bisher nicht zur Eigenanwendung in Verkehr gebracht wurden, im Falle einer Pandemie grundsätzlich auch zur Eigenanwendung verwendet werden können. Eine Verwendung zu diesem Zweck ist nur zulässig, wenn der Hersteller, dessen Bevollmächtigter oder ein Inverkehrbringer dieser Tests bestätigt, dass bei Eigenanwendung ein Sicherheits- und Leistungsniveau erreicht wird, das die Funktionstauglichkeit und die...
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