In-vitro Diagnostik ist ein essentieller Teil der Patientenversorgung. Mit der IVDR ergeben sich im Wesentlichen zwei Möglichkeiten IVDR konforme in-vitro Diagnostik durchzuführen. Zum einen die ausschließliche Nutzung CE-zertifizierter sog. Analysekits oder zum anderen die Nutzung von validierten sog. In-house Verfahren, wobei zukünftig CE-zertifizierte Analysekits angewendet werden sollen, wenn diese verfügbar sind. Sowohl für die kommerziellen Produkte wie auch die in medizinischen Diagnostik-Einrichtungen selbst entwickelten In-house Verfahren sind die Anforderungen an die CE-Zertifizierung bzw. Validierung mit der IVDR gegenüber der vorhergehenden Richtlinie enorm gestiegen. CE-zertifizierte Produkte wird es daher zukünftig nur für häufig durchgeführte Verfahren geben, in-house Verfahren wird es nur
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