IVDR Classification
IVDR Classification is based on the intended purpose and inherent risks of In-Vitro Diagnostic Devices (IVDs), therefore they are classified into classes A, B, C and D considering their intended purpose and inherent risks.
How In-Vitro Diagnostic Devices are classified in IVDR?
In-Vitro Diagnostic Devices or IVDs are classified into classes A, B, C and D considering their intended purpose and their inherent risks. The lowest risk category at Class A, up to the highest at Class D.
Class D (High personal risk, High public health risk)
Examples: Blood grouping ABO, Rhesus (including RHW1), Kell, Kidd and Duffy systems, CHAGAS, Syphilis (used for screening of blood donations), Hepatitis B and C etc.
As per IVDR Classification for Class D IVDs, CE mark could be achieved through the conformity assessment routes:
Quality Management System Assurance [Annex IX] followed by Assessment of Technical Documentation [Annex IX Ch II] followed by Verification by EU Reference Laboratory
OR
Type Examination [Annex X] (includes Technical Documentation) followed by Production Quality Assurance [Annex XI] followed by Verification by EU Reference Laboratory
Class C (High personal risk, Moderate to low public health risk)
Examples: Genetic tests, Companion diagnostics, Blood gas analyzers, Caner markers, Rubella, Neonatal screening for metabolic disorders etc.
As per IVDR Classification for Class C IVDs, CE mark could be achieved through the conformity assessment routes:
Quality Management System Assurance [Annex IX] followed by Assessment of Technical Documentation per generic device [Annex IX 4.4-4.8] followed by For Companion Diagnostics Competent Authority consultation [Annex IX 5.2]
OR
Type Examination [Annex X] (includes Technical Documentation) followed by Production Quality Assurance [Annex XI] followed by For Companion Diagnostics Competent Authority consultation [Annex X 3]
Class B (Moderate to low personal risk, Low public health risk)
Examples: Thyroid function tests, Infertility assays, Clinical Chemistry
As per IVDR Classification for Class B IVDs, CE mark could be achieved through the conformity assessment route
Quality Management System Assurance [Annex IX] followed by Assessment of Technical Documentation per category device [Annex IX 4.4-4.8].
Class A (Low personal risk, Low public health risk)
Instruments, Specimen receptacles, Wash buffers etc.
For Class A IVDs, CE mark could be achieved through the conformity assessment route.
EU Declaration of Conformity [Annex III].
IVDR Classification and Related Rules
Rule 1
This rule applicable for most of the devices in Class D,
(a) determination of infectious load of a life-threatening disease,
(b) transmissible agent in blood, cells, tissues or organs and blood components.
Rule 2
This rule applicable for most of the devices majorly in Class C and few in Class D
Devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration.
Rule 3
Generally majority of the IVD devices falls under this category are in Class C
Device used for (a) sexually transmitted disease (b) foetus or embryo (c) pre-natal screening of women (d) infective disease status or immune status (e) screening, diagnosis, or staging of cancer (f) human genetic testing (g) screening for congenital disorders in the embryo or foetus (h) congenital disorders in new-born babies etc.
Rule 4
Majority of the Devices falls under Class C and few in Class B Intended for self-testing
Note : exemption from devices for the detection of pregnancy, for fertility testing, Cholesterol / Glucose / Erythrocytes / Leucocytes / virus/ bacteria/ urine level determination.
Rule 5
Generally Class A devices falls under this rule.
General laboratory use accessories such as buffer solutions, washing solutions, culture media, histological stains used in IVD procedures and also some instruments for In Vitro procedures and specimen receptacles.
Rule 6
Class B Devices are not covered in any above IVDR classification (1-5) rules
Rule 7
Generally considered in Class B Devices
Devices which are controls without a quantitative or qualitative assigned value.