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Codeliste: DeviceRiskClass_MDR_IVDR

Name Vorgänger ID Definition Type Eingeschränkt für DE M-Nummern
DeviceRiskClass_MDR_IVDRLCLKeine AngabeM486

Codes

FMCG

DIY

HC
Action Code Codewert Beschreibung Definition Grafik Quelle Zusatzinformation 1 Zusatzinformation 2 Zusatzinformation 3 SET Letzte Änderung
NCHNEU_CLASS_AKlasse A In-vitro-Diagnostik - Niedriges RisikoLow-risk as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746Use when additionalTradeItemClassificationSystemCode = 7623.05.2025relevantrelevantrelevant
NCHNEU_CLASS_BKlasse B In-vitro-Diagnostik - Niedriges bis mittleres RisikoLow-Medium risk as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746Use when additionalTradeItemClassificationSystemCode = 7623.05.2025relevantrelevantrelevant
NCHNEU_CLASS_CKlasse C In-vitro-Diagnostik - Mittleres bis hohes RisikoMedium-high as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746Use when additionalTradeItemClassificationSystemCode = 7623.05.2025relevantrelevantrelevant
NCHNEU_CLASS_DKlasse D In-vitro-Diagnostik - Hohes RisikoHigh-risk as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746Use when additionalTradeItemClassificationSystemCode = 7623.05.2025relevantrelevantrelevant
NCHNEU_CLASS_IKlasse I Medizinprodukt - Niedriges RisikoLow-risk as specified in the final European Medical Device Regulation (EU) 2017/745Use when additionalTradeItemClassificationSystemCode = 7623.05.2025relevantrelevantrelevant
NCHNEU_CLASS_IIAKlasse IIa Medizinprodukt - Niedriges bis mittleres RisikoLow-Medium risk as specified in the final European Medical Device Regulation (EU) 2017/745Use when additionalTradeItemClassificationSystemCode = 7623.05.2025relevantrelevantrelevant
NCHNEU_CLASS_IIBKlasse IIb Medizinprodukt - Mittleres bis hohes RisikoMedium-high risk as specified in the final European Medical Device Regulation (EU) 2017/745Use when additionalTradeItemClassificationSystemCode = 7623.05.2025relevantrelevantrelevant
NCHNEU_CLASS_IIIKlasse III Medizinprodukt - Hohes RisikoHigh-risk as specified in the final European Medical Device Regulation (EU) 2017/745Use when additionalTradeItemClassificationSystemCode = 7623.05.2025relevantrelevantrelevant