Whereas the IVD Directive 98/79/EC specifies Notified Body  involvement for only a few high risk IVDs listed in Annex VII, the IVD  Regulation introduces risk-based classification Class A to D, based on IMDR rules and similar to Health Canada and TGA classification rules.

The  outcome is that the conformity assessment process for CE marking for  the majority of IVDs will now necessitate involvement of a Notified  Body, as opposed to self-declaration by the manufacturer under the IVDD.

The  majority of IVDs currently self-certified will now require the services  of a Notified Body in the conformity assessment process to ensure the  safety and performances of IVDs placed on the EU market.

Under  the IVDR, Devices are divided into classes A, B, C and D, taking into  account the intended purpose of the devices and their inherent risks

Class D: Public health and Personal risk - high; i.e. Screening for transmissible agents  and for high risk blood grouping for transfusion, transplantation, cell  administration; life-threatening transmissible agents : Screening   where possible high risk  of propagation, and detection of infectious  load where monitoring determines patient management e.g. Blood groups  ABO,  Rh, Kidd, Duffy, Kell; HIV1 and 2, HTLV I/II, Hep B and C, Chagas,  screening blood for syphilis

Class C: Public  health risk moderate – low; Personal risk - low; i.e. Testing for  compatibility for transfusion, transplantation, cell administration,  excluding high risk blood grouping; tests for Infectious disease /  STI  agents  / cancer biomarkers / Companion diagnostics / genetic testing /  TORCH screening / congenital disorders / monitoring high risk  medicines/substances e.g. blood glucose / most self-test IVDs.

Class B: Public  health risk - low; Personal risk moderate to low i.e. clinical chemistry  tests, some specific self-test IVDs – Class B is also the default ruling  where no other Rule applies.

Class A: Public  health and personal risk - low, e.g. Specimen receptacles; products for  general lab use, accessories with no critical characteristics, buffers,  washes, culture media, histological stains if intended for specific  test; instruments intended for IVD procedures

Classification Rules

Rule 1

Devices  intended to be used for the following purposes are classified as class  D:

  • detection of the presence of, or exposure to, a transmissible  agent in blood, blood components, cells, tissues or organs, or in any of  their derivatives, in order to assess their suitability for  transfusion, transplantation or cell administration;
  • detection of the  presence of, or exposure to, a transmissible agent that causes a  life-threatening disease with a high or suspected high risk of  propagation;  
  • determining the infectious load of a life-threatening  disease where monitoring is critical in the process of patient  management.

Rule 2

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,  are classified as class C, except when intended to determine any of the  following markers:

  • ABO system [A (ABO1), B (ABO2), AB (ABO3)];
  • Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]; —   Kell system [Kel1 (K)]; —  Kidd system [JK1 (Jka), JK2 (Jkb)];
  • Duffy  system [FY1 (Fya), FY2 (Fyb)]; in which case they are classified as  class D.

Rule 3

Devices are classified as class C if they are intended:

  • for detecting the presence of, or exposure to, a sexually transmitted agent;
  • for  detecting the presence in cerebrospinal fluid or blood of an infectious  agent without a high or suspected high risk of propagation;
  • for  detecting the presence of an infectious agent, if there is a  significant risk that an erroneous result would cause death or severe  disability to the individual, foetus or embryo being tested, or to the  individual’s offspring;
  • for pre-natal screening of women in order to determine their immune status towards transmissible agents;
  • for  determining infective disease status or immune status, where there is a  risk that an erroneous result would lead to a patient management  decision resulting in a life-threatening situation for the patient or  for the patient’s offspring;
  • to be used as companion diagnostics;
  • to  be used for disease staging, where there is a risk that an erroneous  result would lead to a patient management decision resulting in a  life-threatening situation for the patient or for the patient’s  offspring;
  • to be used in screening, diagnosis, or staging of cancer;
  • for human genetic testing;
  • for  monitoring of levels of medicinal products, substances or biological  components, when there is a risk that an erroneous result will lead to a  patient management decision resulting in a life-threatening situation  for the patient or for the patient’s offspring;
  • for management of patients suffering from a life-threatening disease or condition;
  • for screening for congenital disorders in the embryo or foetus;
  • for  screening for congenital disorders in new-born babies where failure to  detect and treat such disorders could lead to life-threatening  situations or severe disabilities.

Rule 4

  • Devices  intended for self-testing are classified as class C, except for devices  for the detection of pregnancy, for fertility testing and for  determining cholesterol level, and devices for the detection of glucose,  erythrocytes, leucocytes and bacteria in urine, which are classified as  class B.
  • Devices intended for near-patient testing are classified in their own right.

Rule 5

The following devices are classified as class A:

  • products  for general laboratory use, accessories which possess no critical  characteristics, buffer solutions, washing solutions, and general  culture media and histological stains, intended by the manufacturer to  make them suitable for in vitro diagnostic procedures relating to a  specific examination;
  • instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures;
  • specimen receptacles.

Rule 6

Devices not covered by the above-mentioned classification rules are classified as class B.

Rule 7

Devices which are controls without a quantitative or qualitative assigned value are classified as class B.

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