Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Class D (high risk) e.g. ABO Blood typing

85% of IVDs Notified Body Interaction Required

Class C e.g. Malaria

Class B e.g. Flu A/B

Class A (low risk) e.g. Instruments, calibrators

15% of IVDs Self-Declaration for CE marking

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•Annex VIII •Series of 7 classification rules •Governed by intended purpose •Ordered assessment of device

•Follow the sequence in turn, identify not applicable or maybe applicable, justify most appropriate class

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