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IVDR
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In-vitro-Diagnostika-VO
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Inhaltsverzeichnis
KAPITEL I: EINLEITENDE BESTIMMUNGEN
Art. 1 - Art. 4
KAPITEL II: BEREITSTELLUNG AUF DEM MARKT UND INBETRIEBNAHME VON PRODUKTEN, PFLICHTEN DER WIRTSCHAFTSAKTEURE, CE-KENNZEICHNUNG, FREIER VERKEHR
Art. 5 - Art. 21
KAPITEL III: IDENTIFIZIERUNG UND RÜCKVERFOLGBARKEIT VON PRODUKTEN, REGISTRIERUNG VON PRODUKTEN UND WIRTSCHAFTSAKTEUREN, KURZBERICHT ÜBER SICHERHEIT UND KLINISCHE LEISTUNG, EUROPÄISCHE DATENBANK FÜR MEDIZINPRODUKTE
Art. 22 - Art. 30
KAPITEL IV: BENANNTE STELLEN
Art. 31 - Art. 46
KAPITEL V: KLASSIFIZIERUNG UND KONFORMITÄTSBEWERTUNG
Art. 47 - Art. 55
KAPITEL VI: KLINISCHER NACHWEIS, LEISTUNGSBEWERTUNG UND LEISTUNGSSTUDIEN
Art. 56 - Art. 77
KAPITEL VII: ÜBERWACHUNG NACH DEM INVERKEHRBRINGEN, VIGILANZ UND MARKTÜBERWACHUNG
Art. 78 - Art. 95
KAPITEL VIII: KOOPERATION ZWISCHEN DEN MITGLIEDSTAATEN, DER KOORDINIERUNGSGRUPPE MEDIZINPRODUKTE, EU-REFERENZLABORATORIEN UND PRODUKTREGISTER
Art. 96 - Art. 101
KAPITEL IX: VERTRAULICHKEIT, DATENSCHUTZ, FINANZIERUNG UND SANKTIONEN
Art. 102 - Art. 106
KAPITEL X: SCHLUSSBESTIMMUNGEN
Art. 107 - Art. 113
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