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IVDR Classification

EU IVDR Classification 2017/746

EU 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.

IVDR Classification

How In-Vitro Diagnostic Devices are classified?

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 A for low personal risk, low public health risk devices. Few examples are below.

 

♦  Instruments,

♦  Specimen receptacles,

♦  Wash buffers

♦  etc.

 

As per EU IVDR Classification for Class A devices (Excluding Sterile), CE marking could be achieved through EU Declaration of Conformity [Annex III].

Class B for moderate to low personal risk, low public health risk. Few examples are below.

 

♦  Thyroid function tests,

♦  Infertility assays,

♦  Clinical Chemistry

♦  etc.

 

As per EU IVDR Classification for Class B devices, CE marking for medical devices could be achieved through below 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 C for high personal risk, moderate to low public health risk device. Few examples are below.

 

♦  Genetic tests,

♦  Companion diagnostics,

♦  Blood gas analysers,

♦  Caner markers,

♦  Rubella,

♦  Neonatal screening for metabolic disorders

 

As per EU IVDR Classification for Class C devices, CE marking could be achieved through the any of the below 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]

 

♦  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 D for high personal risk, high public health risk device. Few examples are below.

 

♦  Blood grouping ABO

♦  Rhesus (including RHW1)

♦  Kell

♦  Kidd and Duffy systems

♦  Syphilis (used for screening of blood donations)

♦  Hepatitis B and C

 

As per EU IVDR Classification for Class D devices, CE marking could be achieved through the any of the below 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

 

♦  Type Examination [Annex X] (includes Technical Documentation) followed by Production Quality Assurance [Annex XI] followed by Verification by EU Reference Laboratory

EU IVDR Classification 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 EU IVDR classification (1-5) rules

Rule 7

Generally considered in Class B Devices

 

Devices which are controls without a quantitative or qualitative assigned value.