Module 19 2021

02/06/2021

Classification IVDR

MDD/MDR

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

– Some up-classification (eg software) – Same risk groups (I, IIa, IIb, III)

MDD/MDR risk classification

Examples

Premarket scrutiny by a Notified Body

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

Class III

Heart valve;

Yes

ABO blood groups; HIV infections;

Blood glucose self tests Rubella, toxoplasmosis, CMV, chlamydia

Class IIb Lung ventilator;

Yes

Bone fixation plate;

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;

Class IIa Hypodermic needles;

Yes

Suction equipment; Bandages; Tongue depressors;

General

Class I

No

Tests for cancer; Tests for sexually

Specimen receptacles;

transmitted infections; Companion diagnostics; Human genetic tests;

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• Classification

CLASS

RISK LEVEL (IMDRF)

EXAMPLES

Low individual risk and Low public health risk

Clinical chemistry analyser Prepared culture media

A

10% self certify

Moderate individual risk and/or Low public health risk

Pregnancy self testing Urine test strips

B

R I S K

High individual risk and/or Moderate public health risk

Blood glucose self testing HLA typing PSA screening Rubella test ABO blood donor screening HIV blood diagnostic

C

90% NB scrutiny

High individual risk and High public health risk

D

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