Ärzt:innen nutzen KI-Tools, um Herzen zu tracken, Radiolog:innen setzen Bilderkennungssoftware ein, um Krebszellen früh zu erkennen, und Kliniken greifen auf KI‑gestützte Triage‑ und Symptomchecker zurück, um Patient:innen schneller zu beurteilen. Doch in der EU gelten strenge Regeln: Um ihre Produkte in der EU verkaufen zu können, müssen Hersteller die Produkte nach der Medizinprodukteverordnung (Medical Device Regulation) und der In-vitro-Diagnostik-Regulation (IVDR) prüfen und zertifizieren lassen.
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GD Sante versus GD Connect
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Fraktionen des EU-Parlaments gehen noch weiter
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Hersteller bekommen keine klare Ansage
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Kommission will Anforderung aus AI Act in die MDR überführen
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Planbarkeit für Hersteller, Rückschritt für Patiensicherheit?
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