Updated guidance on classification rules for IVDs

MDCG 2020-16 on classification rules for IVDs has been updated in July 2024 for its third revision. The second update came in February 2023 with a flowchart to help determine whether an IVD is a companion diagnostic (CDx).

The guidance provides clarifications on the classification rules listed in Annex VIII of the IVD Regulation. Essentially, IVDs are classified into classes A, B, C, and D. The device’s intended purpose and its risks must be taken into account when assessing classification.

The updated version of the guidance includes:

• Addition of ‘kit’ definition: “means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof.”
• Revision of examples under rule 3(a) in reference to monkeypox virus
• Revised text under rule 4(a) and rule 5(c):

• Minor revision of example under rule 6 – Change from ”Device intended for the detection of Influenza A/B virus (non-pandemic)” to ”Device intended for the detection of Influenza A/B virus (not highly virulent)”

IVDR classification rules explanation

Annex VIII of the EU IVDR lists 9 rules which determine IVDs’ classes:

1. Rule 1 groups devices used for the detection of, or exposure to, a transmissible agent in blood. This includes blood components, cells, tissues or organs to determine their suitability for transfusion, transplantation or cell administration, but also to detect life-threatening diseases or their the infectious loads.
2. Rule 2 includes devices used for blood grouping. This rule also enhance devices used to determine foeto-maternal blood group incompatibility 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 (with certain exceptions).
3. Rule 3 groups class C devices. Devices are classified as class C when intended for detecting the presence of/determining/be used:
   • a sexually transmitted agent.
   • cerebrospinal fluid or blood of an infectious agent (without high risk of propagation).
   • an infectious agent, given that a wrong result could cause death or severe disability to the individual, foetus, or embryo being tested.
   • immune status towards transmissible agents of pre-natal women.
   • infective disease status or immune status, given that a wrong result would lead to a patient’s life-threatening situation.
   • as companion diagnostics.
   • for disease staging, given that a wrong result would lead to a patient’s life-threatening situation.
   • for cancer staging, screening, and diagnosis.
   • for human genetic testing.
   • monitoring of levels of medicinal products, substances or biological components, given that a wrong result would lead to a patient’s life-threatening situation.
   • for management of patients suffering from a life-threatening disease or condition.
   • for screening for congenital disorders.
4. Rule 4 includes devices for detection of pregnancy, fertility testing and determining cholesterol level. It also includes devices for the detection of glucose, erythrocytes, leucocytes and bacteria in urine. Near-patient testing also belongs to this group.
5. Rule 5 groups products for general laboratory, specimen receptacles use as well as instruments intended to be used for in vitro diagnostic procedures.
6. Devices not covered by the above-mentioned classification rules are classified as class B under rule 6.
7. Devices which are controls without a quantitative or qualitative assigned value are classified as class B under rule 7.

Do you have questions about the classification assessment of your IVDs? Ask your questions here!