Module 19 2021

02/06/2021

Classification IVDD • 20/80

IVDD risk categories

Examples

Annex II List A

ABO blood groups; HIV infections;

Annex II List B Blood glucose self tests Rubella, toxoplasmosis, CMV, chlamydia Self testing Devices for self testing General Tests for cancer; Tests for sexually

transmitted infections; Companion diagnostics; Human genetic tests;

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Classification IVDR

• four risk groups (D,C,B&A) • B, C & D require Notified body scrutiny • significant change (80:20) IVDD risk categories Examples IVDR risk classification

Examples

Annex II List A Annex II List B

Class D ABO blood groups; HIV infections; Emergency epidemics Class C Tests for cancer ; Tests for sexually

ABO blood groups; HIV infections;

Blood glucose self tests PSA PKU Rubella, toxoplasmosis, CMV, chlamydia

transmitted infections ; Companion diagnostics; Human genetic tests; Most devices for self- testing

Self testing Devices for self testing

Class B Pregnancy self-tests; Cholesterol tests; Urine test strips; Class A Clinical chemistry analyser;

General

Tests for cancer; Tests for sexually

Specimen receptacles;

transmitted infections; Companion diagnostics; Human genetic tests;

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