Verordnung des Bundesministers für Soziales, Gesundheit, Pflege und Konsumentenschutz betreffend vorläufige Maßnahmen zur Sicherstellung der Verfügbarkeit von Medizinprodukten
217. Verordnung des Bundesministers für Soziales, Gesundheit, Pflege und Konsumentenschutz betreffend vorläufige Maßnahmen zur Sicherstellung der Verfügbarkeit von Medizinprodukten
Gemäß § 113a Abs. 1 Medizinproduktegesetz (MPG), BGBl. I Nr. 657/1996, zuletzt geändert durch das Bundesgesetz BGBl. I Nr. 23/2020, wird verordnet:
§ 1.
(1) OP-Masken (medizinische Gesichtsmasken), die nicht CE-gekennzeichnet sind, dürfen in Österreich in Verkehr gebracht werden, wenn der Verantwortliche für das Inverkehrbringen bestätigt, dass die einschlägigen Normen eingehalten werden oder bei Nichteinhaltung dieser ein Sicherheits- und Leistungsniveau erreicht wird, das die Funktionstauglichkeit und die Einsatztauglichkeit für den geplanten Zweck gewährleistet.
(2) Die Verantwortlichen für das Inverkehrbringen bestätigen im Wege einer Selbstverpflichtung die Einhaltung dieser Anforderungen und übermitteln diese Bestätigung dem Bundesamt für Sicherheit im Gesundheitswesen.
§ 2.
Die Wiederaufbereitung von OP-Masken (medizinische Gesichtsmasken), die vom Hersteller zur Einmalverwendung vorgesehen sind, ist dann zulässig, wenn die einschlägigen Normen eingehalten werden, bei der Aufbereitung ein Sicherheits- und Leistungsniveau erreicht wird, das die Funktionstauglichkeit und die Einsatztauglichkeit für den geplanten Zweck gewährleistet und die angewandten Aufbereitungsverfahren entsprechend validiert wurden.
§ 3.
Bei der wiederkehrenden Prüfung und messtechnischen Kontrolle ist eine Überschreitung der nach §§ 6 und 7 Medizinproduktebetreiberverordnung (MPBV), BGBl. II Nr. 70/2007 in der geltenden Fassung, vorgesehenen Prüffristen unter der Voraussetzung zulässig, dass unter Einbeziehung des technischen Sicherheitsbeauftragten und des Trägers der Krankenanstalt eine Risikoabschätzung/-analyse durchgeführt und dokumentiert wird.
§ 4.
(1) Die Bestimmung des § 52 MPG, wonach eine klinische Prüfung an Personen, die auf behördliche Anordnung angehalten sind, nicht durchgeführt werden dürfen, gilt nicht für
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